Trial Outcomes & Findings for The Effects of Sedatives on Tobacco Use Disorder (NCT NCT03813121)
NCT ID: NCT03813121
Last Updated: 2022-10-06
Results Overview
drug side effects scale: severity scale from 1 (not at all) to 7 (extremely) for symptoms of nausea, dizziness, sleepiness, strange thoughts, hallucinations, confusion, anxiousness, and headache. The average score across all side effects is reported.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
10 participants
Primary outcome timeframe
about 1 week post infusion
Results posted on
2022-10-06
Participant Flow
Participants must be screened for eligibility before being assigned to a group. Participants deemed ineligible were excluded from the study.
Participant milestones
| Measure |
Placebo Intravenous Infusion
single placebo infusion (saline over 20 minutes)
placebo intravenous infusion: Participants will receive a single placebo infusion
|
Ketamine Intravenous Infusion
single ketamine infusion (0.5 mg/kg over 20 minutes)
ketamine intravenous infusion: Participants will receive a single drug infusion
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
6
|
|
Overall Study
COMPLETED
|
4
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Effects of Sedatives on Tobacco Use Disorder
Baseline characteristics by cohort
| Measure |
Placebo Intravenous Infusion
n=4 Participants
single placebo infusion (saline over 20 minutes)
placebo intravenous infusion: Participants will receive a single placebo infusion
|
Ketamine Intravenous Infusion
n=6 Participants
single ketamine infusion (0.5 mg/kg over 20 minutes)
ketamine intravenous infusion: Participants will receive a single drug infusion
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
37.5 years
STANDARD_DEVIATION 11.2 • n=99 Participants
|
35.5 years
STANDARD_DEVIATION 15.4 • n=107 Participants
|
36.3 years
STANDARD_DEVIATION 13.2 • n=206 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=99 Participants
|
6 participants
n=107 Participants
|
10 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: about 1 week post infusiondrug side effects scale: severity scale from 1 (not at all) to 7 (extremely) for symptoms of nausea, dizziness, sleepiness, strange thoughts, hallucinations, confusion, anxiousness, and headache. The average score across all side effects is reported.
Outcome measures
| Measure |
Placebo Intravenous Infusion
n=4 Participants
single placebo infusion (saline over 20 minutes)
placebo intravenous infusion: Participants will receive a single placebo infusion
|
Ketamine Intravenous Infusion
n=6 Participants
single ketamine infusion (0.5 mg/kg over 20 minutes)
ketamine intravenous infusion: Participants will receive a single drug infusion
|
|---|---|---|
|
Side Effects
|
1.3 score on a scale
Standard Deviation 0.2
|
1.4 score on a scale
Standard Deviation 0.7
|
Adverse Events
Placebo Intravenous Infusion
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Ketamine Intravenous Infusion
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo Intravenous Infusion
n=4 participants at risk
single placebo infusion (saline over 20 minutes)
placebo intravenous infusion: Participants will receive a single placebo infusion
|
Ketamine Intravenous Infusion
n=6 participants at risk
single ketamine infusion (0.5 mg/kg over 20 minutes)
ketamine intravenous infusion: Participants will receive a single drug infusion
|
|---|---|---|
|
General disorders
Nausea
|
0.00%
0/4 • For 7 days post drug administration.
|
16.7%
1/6 • Number of events 1 • For 7 days post drug administration.
|
|
General disorders
Emotional distress
|
0.00%
0/4 • For 7 days post drug administration.
|
16.7%
1/6 • Number of events 1 • For 7 days post drug administration.
|
|
General disorders
motor incoordination
|
0.00%
0/4 • For 7 days post drug administration.
|
16.7%
1/6 • Number of events 1 • For 7 days post drug administration.
|
|
General disorders
Tingling
|
25.0%
1/4 • Number of events 1 • For 7 days post drug administration.
|
0.00%
0/6 • For 7 days post drug administration.
|
Additional Information
Dr. Merideth Addicott
Wake Forest University School of Medicine
Phone: 336-716-7792
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place