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Trial Outcomes & Findings for A Pilot Trial of Nabilone for the Treatment of Obesity (NCT NCT04801641)

NCT ID: NCT04801641

Last Updated: 2026-04-09

Results Overview

Number of SAEs collected to assess nabilone safety

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

18 participants

Primary outcome timeframe

12 weeks of treatment

Results posted on

2026-04-09

Participant Flow

Participant milestones

Participant milestones
Measure
Placebo
Placebo Placebo: Six placebo capsules taken orally twice daily
Low-Dose Nabilone
pms-nabilone titrated to 2 mg daily Nabilone: Titrated to two 0.5 mg capsules and four placebo capsules taken orally twice daily
High-Dose Nabilone
pms-nabilone titrated to 6 mg daily Nabilone: Titrated to six 0.5 mg capsules taken orally twice daily (High-Dose)
Overall Study
STARTED
7
6
5
Overall Study
COMPLETED
4
4
0
Overall Study
NOT COMPLETED
3
2
5

Reasons for withdrawal

Reasons for withdrawal
Measure
Placebo
Placebo Placebo: Six placebo capsules taken orally twice daily
Low-Dose Nabilone
pms-nabilone titrated to 2 mg daily Nabilone: Titrated to two 0.5 mg capsules and four placebo capsules taken orally twice daily
High-Dose Nabilone
pms-nabilone titrated to 6 mg daily Nabilone: Titrated to six 0.5 mg capsules taken orally twice daily (High-Dose)
Overall Study
Withdrew before starting medication
1
1
1
Overall Study
Withdrawal by Subject
2
1
4

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
High-Dose Nabilone
n=4 Participants
pms-nabilone titrated to 6 mg daily Nabilone: Titrated to six 0.5 mg capsules taken orally twice daily (High-Dose)
Total
n=15 Participants
Total of all reporting groups
Placebo
n=6 Participants
Placebo Placebo: Six placebo capsules taken orally twice daily
Low-Dose Nabilone
n=5 Participants
pms-nabilone titrated to 2 mg daily Nabilone: Titrated to two 0.5 mg capsules and four placebo capsules taken orally twice daily (Low-Dose)
Age, Continuous
40.8 years
STANDARD_DEVIATION 3.4 • n=4 Participants
35.5 years
STANDARD_DEVIATION 6.8 • n=15 Participants
34.3 years
STANDARD_DEVIATION 7.6 • n=6 Participants
32.8 years
STANDARD_DEVIATION 6.7 • n=5 Participants
Sex: Female, Male
Female
3 Participants
n=4 Participants
8 Participants
n=15 Participants
2 Participants
n=6 Participants
3 Participants
n=5 Participants
Sex: Female, Male
Male
1 Participants
n=4 Participants
7 Participants
n=15 Participants
4 Participants
n=6 Participants
2 Participants
n=5 Participants
Race and Ethnicity Not Collected
—
0 Participants
Race and Ethnicity were not collected from any participant.
—
—
Region of Enrollment
Canada
4 participants
n=4 Participants
15 participants
n=15 Participants
6 participants
n=6 Participants
5 participants
n=5 Participants
Body mass index (BMI)
33.1 kg/m^2
STANDARD_DEVIATION 3.0 • n=4 Participants
37.7 kg/m^2
STANDARD_DEVIATION 6.7 • n=15 Participants
37.8 kg/m^2
STANDARD_DEVIATION 4.2 • n=6 Participants
41.4 kg/m^2
STANDARD_DEVIATION 9.4 • n=5 Participants
Body weight
90.8 kg
STANDARD_DEVIATION 17.9 • n=4 Participants
107.1 kg
STANDARD_DEVIATION 21.4 • n=15 Participants
112.2 kg
STANDARD_DEVIATION 16.4 • n=6 Participants
114.0 kg
STANDARD_DEVIATION 25.9 • n=5 Participants
Waist circumference
106.5 cm
STANDARD_DEVIATION 14.0 • n=4 Participants
117.8 cm
STANDARD_DEVIATION 18.1 • n=15 Participants
122.1 cm
STANDARD_DEVIATION 15.3 • n=6 Participants
121.7 cm
STANDARD_DEVIATION 23.0 • n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks of treatment

Population: Note that n=1 participant in each arm was randomized but did not actually receive drug (dropped out before the first week of treatment) and thus is not included in the analysis here.

Number of SAEs collected to assess nabilone safety

Outcome measures

Outcome measures
Measure
High-Dose Nabilone
n=4 Participants
pms-nabilone titrated to 6 mg daily Nabilone: Titrated to two 0.5 mg capsules and four placebo capsules taken orally twice daily (Low-Dose) OR Titrated to six 0.5 mg capsules taken orally twice daily (High-Dose)
Placebo
n=6 Participants
Placebo Placebo: Six placebo capsules taken orally twice daily
Low-Dose Nabilone
n=5 Participants
pms-nabilone titrated to 2 mg daily Nabilone: Titrated to two 0.5 mg capsules and four placebo capsules taken orally twice daily (Low-Dose) OR Titrated to six 0.5 mg capsules taken orally twice daily (High-Dose)
Number of SAEs Per Treatment Arm
0 Participants
0 Participants
0 Participants

PRIMARY outcome

Timeframe: 12 weeks of treatment

Number of dropouts collected to assess feasibility of study design and intervention

Outcome measures

Outcome measures
Measure
High-Dose Nabilone
n=5 Participants
pms-nabilone titrated to 6 mg daily Nabilone: Titrated to two 0.5 mg capsules and four placebo capsules taken orally twice daily (Low-Dose) OR Titrated to six 0.5 mg capsules taken orally twice daily (High-Dose)
Placebo
n=7 Participants
Placebo Placebo: Six placebo capsules taken orally twice daily
Low-Dose Nabilone
n=6 Participants
pms-nabilone titrated to 2 mg daily Nabilone: Titrated to two 0.5 mg capsules and four placebo capsules taken orally twice daily (Low-Dose) OR Titrated to six 0.5 mg capsules taken orally twice daily (High-Dose)
Number of Dropouts Per Treatment Arm
5 Participants
3 Participants
2 Participants

SECONDARY outcome

Timeframe: Baseline, one weekly visit for Weeks 1-12, then one discharge visit (Week 13)

Population: Note that all participants with collected data are included in the analysis; the sample size changes in the Outcome Measure Data Table as participants dropped out at different weeks

Change in body weight

Outcome measures

Outcome measures
Measure
High-Dose Nabilone
n=4 Participants
pms-nabilone titrated to 6 mg daily Nabilone: Titrated to two 0.5 mg capsules and four placebo capsules taken orally twice daily (Low-Dose) OR Titrated to six 0.5 mg capsules taken orally twice daily (High-Dose)
Placebo
n=6 Participants
Placebo Placebo: Six placebo capsules taken orally twice daily
Low-Dose Nabilone
n=5 Participants
pms-nabilone titrated to 2 mg daily Nabilone: Titrated to two 0.5 mg capsules and four placebo capsules taken orally twice daily (Low-Dose) OR Titrated to six 0.5 mg capsules taken orally twice daily (High-Dose)
Body Weight
Week 12
—
123.0 kg
Standard Deviation 17.0
113.8 kg
Standard Deviation 22.8
Body Weight
Week 13
—
124.5 kg
Standard Deviation 17.6
111.5 kg
Standard Deviation 21.7
Body Weight
Baseline
90.8 kg
Standard Deviation 17.9
112.2 kg
Standard Deviation 16.4
114.0 kg
Standard Deviation 25.9
Body Weight
Week 1
90.8 kg
Standard Deviation 17.2
113.9 kg
Standard Deviation 17.7
112.8 kg
Standard Deviation 22.9
Body Weight
Week 6
—
116.7 kg
Standard Deviation 16.9
111.5 kg
Standard Deviation 22.3
Body Weight
Week 7
—
120.8 kg
Standard Deviation 12.2
111.2 kg
Standard Deviation 22.2
Body Weight
Week 8
—
124.4 kg
Standard Deviation 15.0
111.7 kg
Standard Deviation 22.6
Body Weight
Week 9
—
122.2 kg
Standard Deviation 15.2
111.5 kg
Standard Deviation 21.8
Body Weight
Week 10
—
122.1 kg
Standard Deviation 15.1
110.9 kg
Standard Deviation 23.0
Body Weight
Week 11
—
123.4 kg
Standard Deviation 16.0
110.5 kg
Standard Deviation 21.6
Body Weight
Week 2
93.8 kg
Standard Deviation 16.7
113.3 kg
Standard Deviation 16.6
114.2 kg
Standard Deviation 23.2
Body Weight
Week 3
99.5 kg
Standard Deviation 20.5
113.1 kg
Standard Deviation 17.3
113.0 kg
Standard Deviation 22.8
Body Weight
Week 4
—
113.4 kg
Standard Deviation 17.2
113.4 kg
Standard Deviation 23.1
Body Weight
Week 5
—
117.7 kg
Standard Deviation 17.7
111.7 kg
Standard Deviation 22.1

SECONDARY outcome

Timeframe: One scan at baseline and one scan at Week 12

Population: Participation in the imaging procedures in this trial was optional; no participants have data for any imaging measures (including this measure, which is abdominal MRI).

Change in abdominal fat, as measured by abdominal MRI

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Blood drawn at baseline, Week 5, Week 9, and Week 12

Population: Note that all participants with collected data are included in the analysis; the sample size changes in the Outcome Measure Data Table as participants dropped out at different weeks

Change in metabolic biomarker (blood levels of glucose)

Outcome measures

Outcome measures
Measure
High-Dose Nabilone
n=4 Participants
pms-nabilone titrated to 6 mg daily Nabilone: Titrated to two 0.5 mg capsules and four placebo capsules taken orally twice daily (Low-Dose) OR Titrated to six 0.5 mg capsules taken orally twice daily (High-Dose)
Placebo
n=6 Participants
Placebo Placebo: Six placebo capsules taken orally twice daily
Low-Dose Nabilone
n=5 Participants
pms-nabilone titrated to 2 mg daily Nabilone: Titrated to two 0.5 mg capsules and four placebo capsules taken orally twice daily (Low-Dose) OR Titrated to six 0.5 mg capsules taken orally twice daily (High-Dose)
Blood Glucose Levels
Week 1 (baseline)
5.0 mmol/L
Standard Deviation 0.4
6.5 mmol/L
Standard Deviation 1.3
5.9 mmol/L
Standard Deviation 0.6
Blood Glucose Levels
Week 5
—
5.2 mmol/L
Standard Deviation 0.5
5.3 mmol/L
Standard Deviation 0.5
Blood Glucose Levels
Week 9
—
5.6 mmol/L
Standard Deviation 0.9
5.4 mmol/L
Standard Deviation 0.2
Blood Glucose Levels
Week 12
—
5.9 mmol/L
Standard Deviation 1.2
5.5 mmol/L
Standard Deviation 0.2

SECONDARY outcome

Timeframe: Blood drawn at baseline, Week 5, Week 9, and Week 12

Population: Note that all participants with collected data are included in the analysis; the sample size changes in the Outcome Measure Data Table as participants dropped out at different weeks (for this measure specifically, there was also some missing data from enrolled participants)

Change in metabolic biomarker (blood levels of insulin)

Outcome measures

Outcome measures
Measure
High-Dose Nabilone
n=3 Participants
pms-nabilone titrated to 6 mg daily Nabilone: Titrated to two 0.5 mg capsules and four placebo capsules taken orally twice daily (Low-Dose) OR Titrated to six 0.5 mg capsules taken orally twice daily (High-Dose)
Placebo
n=4 Participants
Placebo Placebo: Six placebo capsules taken orally twice daily
Low-Dose Nabilone
n=3 Participants
pms-nabilone titrated to 2 mg daily Nabilone: Titrated to two 0.5 mg capsules and four placebo capsules taken orally twice daily (Low-Dose) OR Titrated to six 0.5 mg capsules taken orally twice daily (High-Dose)
Blood Insulin Levels
Week 1 (baseline)
89.7 pmol/L
Standard Deviation 53.4
425.8 pmol/L
Standard Deviation 386.4
243.0 pmol/L
Standard Deviation 116.0
Blood Insulin Levels
Week 5
—
174.3 pmol/L
Standard Deviation 200.0
76.3 pmol/L
Standard Deviation 40.7
Blood Insulin Levels
Week 9
—
247.8 pmol/L
Standard Deviation 204.6
88.5 pmol/L
Standard Deviation 5.0
Blood Insulin Levels
Week 12
—
456.3 pmol/L
Standard Deviation 343.8
89.7 pmol/L
Standard Deviation 83.4

SECONDARY outcome

Timeframe: Blood drawn at baseline, Week 5, Week 9, and Week 12

Population: Note that all participants with collected data are included in the analysis; the sample size changes in the Outcome Measure Data Table as participants dropped out at different weeks (for this measure specifically, there was also some missing data from enrolled participants)

Change in metabolic biomarker (blood triglyceride levels)

Outcome measures

Outcome measures
Measure
High-Dose Nabilone
n=3 Participants
pms-nabilone titrated to 6 mg daily Nabilone: Titrated to two 0.5 mg capsules and four placebo capsules taken orally twice daily (Low-Dose) OR Titrated to six 0.5 mg capsules taken orally twice daily (High-Dose)
Placebo
n=4 Participants
Placebo Placebo: Six placebo capsules taken orally twice daily
Low-Dose Nabilone
n=3 Participants
pms-nabilone titrated to 2 mg daily Nabilone: Titrated to two 0.5 mg capsules and four placebo capsules taken orally twice daily (Low-Dose) OR Titrated to six 0.5 mg capsules taken orally twice daily (High-Dose)
Blood Triglyceride Levels
Week 1 (baseline)
2.6 mmol/L
Standard Deviation 0.7
1.5 mmol/L
Standard Deviation 0.8
2.1 mmol/L
Standard Deviation 1.2
Blood Triglyceride Levels
Week 5
—
1.0 mmol/L
Standard Deviation 0.4
1.8 mmol/L
Standard Deviation 1.0
Blood Triglyceride Levels
Week 9
—
1.5 mmol/L
Standard Deviation 0.6
1.1 mmol/L
Standard Deviation 0.9
Blood Triglyceride Levels
Week 12
—
1.5 mmol/L
Standard Deviation 0.5
1.8 mmol/L
Standard Deviation 0.8

SECONDARY outcome

Timeframe: Blood drawn at baseline, Week 5, Week 9, and Week 12

Population: Note that all participants with collected data are included in the analysis; the sample size changes in the Outcome Measure Data Table as participants dropped out at different weeks (for this measure specifically, there was also some missing data from enrolled participants)

Change in metabolic biomarker (blood levels of HDL and LDL \[total cholesterol\])

Outcome measures

Outcome measures
Measure
High-Dose Nabilone
n=3 Participants
pms-nabilone titrated to 6 mg daily Nabilone: Titrated to two 0.5 mg capsules and four placebo capsules taken orally twice daily (Low-Dose) OR Titrated to six 0.5 mg capsules taken orally twice daily (High-Dose)
Placebo
n=4 Participants
Placebo Placebo: Six placebo capsules taken orally twice daily
Low-Dose Nabilone
n=3 Participants
pms-nabilone titrated to 2 mg daily Nabilone: Titrated to two 0.5 mg capsules and four placebo capsules taken orally twice daily (Low-Dose) OR Titrated to six 0.5 mg capsules taken orally twice daily (High-Dose)
Blood Cholesterol Levels
Week 1 (baseline)
5.6 mmol/L
Standard Deviation 0.06
4.5 mmol/L
Standard Deviation 1.0
4.9 mmol/L
Standard Deviation 0.7
Blood Cholesterol Levels
Week 5
—
4.5 mmol/L
Standard Deviation 0.9
4.6 mmol/L
Standard Deviation 0.6
Blood Cholesterol Levels
Week 9
—
4.8 mmol/L
Standard Deviation 0.9
4.0 mmol/L
Standard Deviation 0.1
Blood Cholesterol Levels
Week 12
—
4.9 mmol/L
Standard Deviation 0.9
4.5 mmol/L
Standard Deviation 0.5

SECONDARY outcome

Timeframe: Blood drawn at baseline, Week 5, Week 9, and Week 12

Population: Blood samples were lost in an unfortunate shipment mistake; no data was salvageable

Change in hunger-related hormones (blood levels of leptin)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Blood drawn at baseline, Week 5, Week 9, and Week 12

Population: Blood samples were lost in an unfortunate shipment mistake; no data was salvageable

Change in hunger-related hormones (blood levels of ghrelin)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Blood drawn at baseline, Week 5, Week 9, and Week 12

Population: Blood samples were lost in an unfortunate shipment mistake; no data was salvageable

Change in hunger-related hormones (blood levels of PYY)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: Number of participants analyzed reflects participants who returned fecal samples at both baseline and Week 12 visits (with either of these samples missing, it is not possible to calculate a change in beta diversity)

Stool samples collected for quantification of gut microbiome composition; outcome measure is change in beta diversity (Bray-Curtis dissimilarity metric) from baseline to Week 12. The Bray-Curtis dissimilarity is bounded between 0 and 1, where 0 means the two sites have the same composition (i.e., pre and post samples share all the species), and 1 means the two sites do not share any species.

Outcome measures

Outcome measures
Measure
High-Dose Nabilone
pms-nabilone titrated to 6 mg daily Nabilone: Titrated to two 0.5 mg capsules and four placebo capsules taken orally twice daily (Low-Dose) OR Titrated to six 0.5 mg capsules taken orally twice daily (High-Dose)
Placebo
n=4 Participants
Placebo Placebo: Six placebo capsules taken orally twice daily
Low-Dose Nabilone
n=5 Participants
pms-nabilone titrated to 2 mg daily Nabilone: Titrated to two 0.5 mg capsules and four placebo capsules taken orally twice daily (Low-Dose) OR Titrated to six 0.5 mg capsules taken orally twice daily (High-Dose)
Gut Microbiota
—
0.238556962 Proportion
Standard Deviation 0.034479085
0.405623381 Proportion
Standard Deviation 0.104184176

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: Participation in the imaging procedures in this trial was optional; no participants have data for any imaging measures

Task-based fMRI to determine differences in neural reactivity to food vs. control pictures

Outcome measures

Outcome data not reported

Adverse Events

Placebo

Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths

Low-Dose Nabilone

Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths

High-Dose Nabilone

Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Placebo
n=6 participants at risk
Placebo Placebo: Six placebo capsules taken orally twice daily
Low-Dose Nabilone
n=5 participants at risk
pms-nabilone titrated to 2 mg daily Nabilone: Titrated to two 0.5 mg capsules and four placebo capsules taken orally twice daily (Low-Dose) OR Titrated to six 0.5 mg capsules taken orally twice daily (High-Dose)
High-Dose Nabilone
n=4 participants at risk
pms-nabilone titrated to 6 mg daily Nabilone: Titrated to two 0.5 mg capsules and four placebo capsules taken orally twice daily (Low-Dose) OR Titrated to six 0.5 mg capsules taken orally twice daily (High-Dose)
Gastrointestinal disorders
Diarrhea
0.00%
0/6 • Adverse event data were collected over a period of three months for each participant (i.e., while they were enrolled in the trial). There was no additional follow up, unless any participant had an ongoing adverse event at discharge.
40.0%
2/5 • Adverse event data were collected over a period of three months for each participant (i.e., while they were enrolled in the trial). There was no additional follow up, unless any participant had an ongoing adverse event at discharge.
25.0%
1/4 • Adverse event data were collected over a period of three months for each participant (i.e., while they were enrolled in the trial). There was no additional follow up, unless any participant had an ongoing adverse event at discharge.
Gastrointestinal disorders
Nausea
16.7%
1/6 • Adverse event data were collected over a period of three months for each participant (i.e., while they were enrolled in the trial). There was no additional follow up, unless any participant had an ongoing adverse event at discharge.
20.0%
1/5 • Adverse event data were collected over a period of three months for each participant (i.e., while they were enrolled in the trial). There was no additional follow up, unless any participant had an ongoing adverse event at discharge.
25.0%
1/4 • Adverse event data were collected over a period of three months for each participant (i.e., while they were enrolled in the trial). There was no additional follow up, unless any participant had an ongoing adverse event at discharge.
Gastrointestinal disorders
Constipation
0.00%
0/6 • Adverse event data were collected over a period of three months for each participant (i.e., while they were enrolled in the trial). There was no additional follow up, unless any participant had an ongoing adverse event at discharge.
20.0%
1/5 • Adverse event data were collected over a period of three months for each participant (i.e., while they were enrolled in the trial). There was no additional follow up, unless any participant had an ongoing adverse event at discharge.
25.0%
1/4 • Adverse event data were collected over a period of three months for each participant (i.e., while they were enrolled in the trial). There was no additional follow up, unless any participant had an ongoing adverse event at discharge.
Nervous system disorders
Difficulty concentrating
0.00%
0/6 • Adverse event data were collected over a period of three months for each participant (i.e., while they were enrolled in the trial). There was no additional follow up, unless any participant had an ongoing adverse event at discharge.
40.0%
2/5 • Adverse event data were collected over a period of three months for each participant (i.e., while they were enrolled in the trial). There was no additional follow up, unless any participant had an ongoing adverse event at discharge.
0.00%
0/4 • Adverse event data were collected over a period of three months for each participant (i.e., while they were enrolled in the trial). There was no additional follow up, unless any participant had an ongoing adverse event at discharge.
Psychiatric disorders
Anxiety
0.00%
0/6 • Adverse event data were collected over a period of three months for each participant (i.e., while they were enrolled in the trial). There was no additional follow up, unless any participant had an ongoing adverse event at discharge.
20.0%
1/5 • Adverse event data were collected over a period of three months for each participant (i.e., while they were enrolled in the trial). There was no additional follow up, unless any participant had an ongoing adverse event at discharge.
0.00%
0/4 • Adverse event data were collected over a period of three months for each participant (i.e., while they were enrolled in the trial). There was no additional follow up, unless any participant had an ongoing adverse event at discharge.
Musculoskeletal and connective tissue disorders
Back pain
0.00%
0/6 • Adverse event data were collected over a period of three months for each participant (i.e., while they were enrolled in the trial). There was no additional follow up, unless any participant had an ongoing adverse event at discharge.
20.0%
1/5 • Adverse event data were collected over a period of three months for each participant (i.e., while they were enrolled in the trial). There was no additional follow up, unless any participant had an ongoing adverse event at discharge.
0.00%
0/4 • Adverse event data were collected over a period of three months for each participant (i.e., while they were enrolled in the trial). There was no additional follow up, unless any participant had an ongoing adverse event at discharge.
Eye disorders
Blurred vision
0.00%
0/6 • Adverse event data were collected over a period of three months for each participant (i.e., while they were enrolled in the trial). There was no additional follow up, unless any participant had an ongoing adverse event at discharge.
20.0%
1/5 • Adverse event data were collected over a period of three months for each participant (i.e., while they were enrolled in the trial). There was no additional follow up, unless any participant had an ongoing adverse event at discharge.
0.00%
0/4 • Adverse event data were collected over a period of three months for each participant (i.e., while they were enrolled in the trial). There was no additional follow up, unless any participant had an ongoing adverse event at discharge.
General disorders
Dry throat
16.7%
1/6 • Adverse event data were collected over a period of three months for each participant (i.e., while they were enrolled in the trial). There was no additional follow up, unless any participant had an ongoing adverse event at discharge.
0.00%
0/5 • Adverse event data were collected over a period of three months for each participant (i.e., while they were enrolled in the trial). There was no additional follow up, unless any participant had an ongoing adverse event at discharge.
0.00%
0/4 • Adverse event data were collected over a period of three months for each participant (i.e., while they were enrolled in the trial). There was no additional follow up, unless any participant had an ongoing adverse event at discharge.
Cardiac disorders
Fast heartbeat
16.7%
1/6 • Adverse event data were collected over a period of three months for each participant (i.e., while they were enrolled in the trial). There was no additional follow up, unless any participant had an ongoing adverse event at discharge.
0.00%
0/5 • Adverse event data were collected over a period of three months for each participant (i.e., while they were enrolled in the trial). There was no additional follow up, unless any participant had an ongoing adverse event at discharge.
0.00%
0/4 • Adverse event data were collected over a period of three months for each participant (i.e., while they were enrolled in the trial). There was no additional follow up, unless any participant had an ongoing adverse event at discharge.
Renal and urinary disorders
Frequent urination
0.00%
0/6 • Adverse event data were collected over a period of three months for each participant (i.e., while they were enrolled in the trial). There was no additional follow up, unless any participant had an ongoing adverse event at discharge.
0.00%
0/5 • Adverse event data were collected over a period of three months for each participant (i.e., while they were enrolled in the trial). There was no additional follow up, unless any participant had an ongoing adverse event at discharge.
25.0%
1/4 • Adverse event data were collected over a period of three months for each participant (i.e., while they were enrolled in the trial). There was no additional follow up, unless any participant had an ongoing adverse event at discharge.
General disorders
Shakiness
16.7%
1/6 • Adverse event data were collected over a period of three months for each participant (i.e., while they were enrolled in the trial). There was no additional follow up, unless any participant had an ongoing adverse event at discharge.
0.00%
0/5 • Adverse event data were collected over a period of three months for each participant (i.e., while they were enrolled in the trial). There was no additional follow up, unless any participant had an ongoing adverse event at discharge.
0.00%
0/4 • Adverse event data were collected over a period of three months for each participant (i.e., while they were enrolled in the trial). There was no additional follow up, unless any participant had an ongoing adverse event at discharge.
Nervous system disorders
Loss of appetite
0.00%
0/6 • Adverse event data were collected over a period of three months for each participant (i.e., while they were enrolled in the trial). There was no additional follow up, unless any participant had an ongoing adverse event at discharge.
20.0%
1/5 • Adverse event data were collected over a period of three months for each participant (i.e., while they were enrolled in the trial). There was no additional follow up, unless any participant had an ongoing adverse event at discharge.
0.00%
0/4 • Adverse event data were collected over a period of three months for each participant (i.e., while they were enrolled in the trial). There was no additional follow up, unless any participant had an ongoing adverse event at discharge.
Reproductive system and breast disorders
Menarche (unexpected period)
0.00%
0/6 • Adverse event data were collected over a period of three months for each participant (i.e., while they were enrolled in the trial). There was no additional follow up, unless any participant had an ongoing adverse event at discharge.
0.00%
0/5 • Adverse event data were collected over a period of three months for each participant (i.e., while they were enrolled in the trial). There was no additional follow up, unless any participant had an ongoing adverse event at discharge.
25.0%
1/4 • Adverse event data were collected over a period of three months for each participant (i.e., while they were enrolled in the trial). There was no additional follow up, unless any participant had an ongoing adverse event at discharge.
Musculoskeletal and connective tissue disorders
Muscle weakness
16.7%
1/6 • Adverse event data were collected over a period of three months for each participant (i.e., while they were enrolled in the trial). There was no additional follow up, unless any participant had an ongoing adverse event at discharge.
0.00%
0/5 • Adverse event data were collected over a period of three months for each participant (i.e., while they were enrolled in the trial). There was no additional follow up, unless any participant had an ongoing adverse event at discharge.
0.00%
0/4 • Adverse event data were collected over a period of three months for each participant (i.e., while they were enrolled in the trial). There was no additional follow up, unless any participant had an ongoing adverse event at discharge.
Psychiatric disorders
Nightmares
0.00%
0/6 • Adverse event data were collected over a period of three months for each participant (i.e., while they were enrolled in the trial). There was no additional follow up, unless any participant had an ongoing adverse event at discharge.
0.00%
0/5 • Adverse event data were collected over a period of three months for each participant (i.e., while they were enrolled in the trial). There was no additional follow up, unless any participant had an ongoing adverse event at discharge.
25.0%
1/4 • Adverse event data were collected over a period of three months for each participant (i.e., while they were enrolled in the trial). There was no additional follow up, unless any participant had an ongoing adverse event at discharge.
Nervous system disorders
Poor memory
0.00%
0/6 • Adverse event data were collected over a period of three months for each participant (i.e., while they were enrolled in the trial). There was no additional follow up, unless any participant had an ongoing adverse event at discharge.
20.0%
1/5 • Adverse event data were collected over a period of three months for each participant (i.e., while they were enrolled in the trial). There was no additional follow up, unless any participant had an ongoing adverse event at discharge.
0.00%
0/4 • Adverse event data were collected over a period of three months for each participant (i.e., while they were enrolled in the trial). There was no additional follow up, unless any participant had an ongoing adverse event at discharge.
Nervous system disorders
Headache
16.7%
1/6 • Adverse event data were collected over a period of three months for each participant (i.e., while they were enrolled in the trial). There was no additional follow up, unless any participant had an ongoing adverse event at discharge.
20.0%
1/5 • Adverse event data were collected over a period of three months for each participant (i.e., while they were enrolled in the trial). There was no additional follow up, unless any participant had an ongoing adverse event at discharge.
50.0%
2/4 • Adverse event data were collected over a period of three months for each participant (i.e., while they were enrolled in the trial). There was no additional follow up, unless any participant had an ongoing adverse event at discharge.
Nervous system disorders
Insomnia
33.3%
2/6 • Adverse event data were collected over a period of three months for each participant (i.e., while they were enrolled in the trial). There was no additional follow up, unless any participant had an ongoing adverse event at discharge.
40.0%
2/5 • Adverse event data were collected over a period of three months for each participant (i.e., while they were enrolled in the trial). There was no additional follow up, unless any participant had an ongoing adverse event at discharge.
0.00%
0/4 • Adverse event data were collected over a period of three months for each participant (i.e., while they were enrolled in the trial). There was no additional follow up, unless any participant had an ongoing adverse event at discharge.
Nervous system disorders
Intoxication
0.00%
0/6 • Adverse event data were collected over a period of three months for each participant (i.e., while they were enrolled in the trial). There was no additional follow up, unless any participant had an ongoing adverse event at discharge.
20.0%
1/5 • Adverse event data were collected over a period of three months for each participant (i.e., while they were enrolled in the trial). There was no additional follow up, unless any participant had an ongoing adverse event at discharge.
75.0%
3/4 • Adverse event data were collected over a period of three months for each participant (i.e., while they were enrolled in the trial). There was no additional follow up, unless any participant had an ongoing adverse event at discharge.
Nervous system disorders
Lightheadedness
16.7%
1/6 • Adverse event data were collected over a period of three months for each participant (i.e., while they were enrolled in the trial). There was no additional follow up, unless any participant had an ongoing adverse event at discharge.
40.0%
2/5 • Adverse event data were collected over a period of three months for each participant (i.e., while they were enrolled in the trial). There was no additional follow up, unless any participant had an ongoing adverse event at discharge.
25.0%
1/4 • Adverse event data were collected over a period of three months for each participant (i.e., while they were enrolled in the trial). There was no additional follow up, unless any participant had an ongoing adverse event at discharge.
General disorders
Dry mouth
50.0%
3/6 • Adverse event data were collected over a period of three months for each participant (i.e., while they were enrolled in the trial). There was no additional follow up, unless any participant had an ongoing adverse event at discharge.
100.0%
5/5 • Adverse event data were collected over a period of three months for each participant (i.e., while they were enrolled in the trial). There was no additional follow up, unless any participant had an ongoing adverse event at discharge.
75.0%
3/4 • Adverse event data were collected over a period of three months for each participant (i.e., while they were enrolled in the trial). There was no additional follow up, unless any participant had an ongoing adverse event at discharge.
Nervous system disorders
Drowsiness
0.00%
0/6 • Adverse event data were collected over a period of three months for each participant (i.e., while they were enrolled in the trial). There was no additional follow up, unless any participant had an ongoing adverse event at discharge.
60.0%
3/5 • Adverse event data were collected over a period of three months for each participant (i.e., while they were enrolled in the trial). There was no additional follow up, unless any participant had an ongoing adverse event at discharge.
100.0%
4/4 • Adverse event data were collected over a period of three months for each participant (i.e., while they were enrolled in the trial). There was no additional follow up, unless any participant had an ongoing adverse event at discharge.
Nervous system disorders
Increased appetite
33.3%
2/6 • Adverse event data were collected over a period of three months for each participant (i.e., while they were enrolled in the trial). There was no additional follow up, unless any participant had an ongoing adverse event at discharge.
40.0%
2/5 • Adverse event data were collected over a period of three months for each participant (i.e., while they were enrolled in the trial). There was no additional follow up, unless any participant had an ongoing adverse event at discharge.
75.0%
3/4 • Adverse event data were collected over a period of three months for each participant (i.e., while they were enrolled in the trial). There was no additional follow up, unless any participant had an ongoing adverse event at discharge.
Nervous system disorders
Decreased appetite
33.3%
2/6 • Adverse event data were collected over a period of three months for each participant (i.e., while they were enrolled in the trial). There was no additional follow up, unless any participant had an ongoing adverse event at discharge.
60.0%
3/5 • Adverse event data were collected over a period of three months for each participant (i.e., while they were enrolled in the trial). There was no additional follow up, unless any participant had an ongoing adverse event at discharge.
25.0%
1/4 • Adverse event data were collected over a period of three months for each participant (i.e., while they were enrolled in the trial). There was no additional follow up, unless any participant had an ongoing adverse event at discharge.
Nervous system disorders
Dizziness
0.00%
0/6 • Adverse event data were collected over a period of three months for each participant (i.e., while they were enrolled in the trial). There was no additional follow up, unless any participant had an ongoing adverse event at discharge.
60.0%
3/5 • Adverse event data were collected over a period of three months for each participant (i.e., while they were enrolled in the trial). There was no additional follow up, unless any participant had an ongoing adverse event at discharge.
75.0%
3/4 • Adverse event data were collected over a period of three months for each participant (i.e., while they were enrolled in the trial). There was no additional follow up, unless any participant had an ongoing adverse event at discharge.
Respiratory, thoracic and mediastinal disorders
Shortness of breath
16.7%
1/6 • Adverse event data were collected over a period of three months for each participant (i.e., while they were enrolled in the trial). There was no additional follow up, unless any participant had an ongoing adverse event at discharge.
0.00%
0/5 • Adverse event data were collected over a period of three months for each participant (i.e., while they were enrolled in the trial). There was no additional follow up, unless any participant had an ongoing adverse event at discharge.
0.00%
0/4 • Adverse event data were collected over a period of three months for each participant (i.e., while they were enrolled in the trial). There was no additional follow up, unless any participant had an ongoing adverse event at discharge.

Additional Information

Dr. Bernard Le Foll

Centre for Addiction and Mental Health

Phone: 416-535-8501

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place