Trial Outcomes & Findings for Combined Pharmacotherapy for Cannabis Dependency (NCT NCT01020019)
NCT ID: NCT01020019
Last Updated: 2019-04-24
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
156 participants
Primary outcome timeframe
reported daily for 12 weeks/ or study participation
Results posted on
2019-04-24
Participant Flow
Participants were treated at the Substance Treatment and Research Service (STARS) of Columbia University/ New York State Psychiatric Institute (NYSPI). Study enrollment occurred from January 2010 through May 2014 with study completion in September 2014.
The study included a one-week placebo lead-in phase. Participants were randomized at the end of the placebo lead-in phase and those who reported marijuana use less than once a week during the lead-in phase were considered placebo responders and were not randomized. A total of 34 participants discontinued prior to randomization for various reasons.
Participant milestones
| Measure |
Placebo
Lofex. matched placebo Dronabinol placebo
Placebo: Placebo control
|
Lofexidine and Dronabinol
Maintained at 1.8mg/day Lofex. and 60 mg/day of Dronabinol
Lofexidine and Dronabinol: Lofex: .6 mg/ TID Dronabinol: 20 mg/TID
|
|---|---|---|
|
Overall Study
STARTED
|
61
|
61
|
|
Overall Study
COMPLETED
|
35
|
32
|
|
Overall Study
NOT COMPLETED
|
26
|
29
|
Reasons for withdrawal
| Measure |
Placebo
Lofex. matched placebo Dronabinol placebo
Placebo: Placebo control
|
Lofexidine and Dronabinol
Maintained at 1.8mg/day Lofex. and 60 mg/day of Dronabinol
Lofexidine and Dronabinol: Lofex: .6 mg/ TID Dronabinol: 20 mg/TID
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
21
|
18
|
|
Overall Study
Adverse Event
|
1
|
5
|
|
Overall Study
not interested in treatment
|
4
|
4
|
|
Overall Study
moving
|
0
|
2
|
Baseline Characteristics
Combined Pharmacotherapy for Cannabis Dependency
Baseline characteristics by cohort
| Measure |
Placebo
n=61 Participants
Lofex. matched placebo Dronabinol placebo
Placebo: Placebo control
|
Lofexidine and Dronabinol
n=61 Participants
Maintained at 1.8mg/day Lofex. and 60 mg/day of Dronabinol
Lofexidine and Dronabinol: Lofex: .6 mg/ TID Dronabinol: 20 mg/TID
|
Total
n=122 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
35.4 years
STANDARD_DEVIATION 10.8 • n=99 Participants
|
34.8 years
STANDARD_DEVIATION 11.2 • n=107 Participants
|
35.2 years
STANDARD_DEVIATION 10.9 • n=206 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
38 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
45 Participants
n=99 Participants
|
39 Participants
n=107 Participants
|
84 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
15 participants
n=99 Participants
|
17 participants
n=107 Participants
|
32 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black
|
17 participants
n=99 Participants
|
18 participants
n=107 Participants
|
35 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
26 participants
n=99 Participants
|
21 participants
n=107 Participants
|
47 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 participants
n=99 Participants
|
5 participants
n=107 Participants
|
8 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: reported daily for 12 weeks/ or study participationOutcome measures
| Measure |
Placebo
n=61 Participants
Lofex. matched placebo Dronabinol placebo
Placebo: Placebo control
|
Lofexidine and Dronabinol
n=61 Participants
Maintained at 1.8mg/day Lofex. and 60 mg/day of Dronabinol
Lofexidine and Dronabinol: Lofex: .6 mg/ TID Dronabinol: 20 mg/TID
|
|---|---|---|
|
21 Days of Consecutive Abstinence as Measured by the Time-line Followback.
|
18 participants
|
17 participants
|
Adverse Events
Placebo
Serious events: 1 serious events
Other events: 46 other events
Deaths: 0 deaths
Lofexidine and Dronabinol
Serious events: 1 serious events
Other events: 47 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=61 participants at risk
Lofex. matched placebo Dronabinol placebo
Placebo: Placebo control
|
Lofexidine and Dronabinol
n=61 participants at risk
Maintained at 1.8mg/day Lofex. and 60 mg/day of Dronabinol
Lofexidine and Dronabinol: Lofex: .6 mg/ TID Dronabinol: 20 mg/TID
|
|---|---|---|
|
Gastrointestinal disorders
abdominal pain
|
0.00%
0/61 • 12 weeks of trial or participants length of participation
|
1.6%
1/61 • Number of events 1 • 12 weeks of trial or participants length of participation
|
|
Psychiatric disorders
detoxification
|
1.6%
1/61 • Number of events 1 • 12 weeks of trial or participants length of participation
|
0.00%
0/61 • 12 weeks of trial or participants length of participation
|
Other adverse events
| Measure |
Placebo
n=61 participants at risk
Lofex. matched placebo Dronabinol placebo
Placebo: Placebo control
|
Lofexidine and Dronabinol
n=61 participants at risk
Maintained at 1.8mg/day Lofex. and 60 mg/day of Dronabinol
Lofexidine and Dronabinol: Lofex: .6 mg/ TID Dronabinol: 20 mg/TID
|
|---|---|---|
|
General disorders
dry mouth
|
9.8%
6/61 • Number of events 6 • 12 weeks of trial or participants length of participation
|
44.3%
27/61 • Number of events 27 • 12 weeks of trial or participants length of participation
|
|
General disorders
fatigue
|
24.6%
15/61 • Number of events 15 • 12 weeks of trial or participants length of participation
|
42.6%
26/61 • Number of events 26 • 12 weeks of trial or participants length of participation
|
|
General disorders
dizzy
|
19.7%
12/61 • Number of events 12 • 12 weeks of trial or participants length of participation
|
34.4%
21/61 • Number of events 21 • 12 weeks of trial or participants length of participation
|
|
General disorders
insomnia
|
21.3%
13/61 • Number of events 13 • 12 weeks of trial or participants length of participation
|
21.3%
13/61 • Number of events 13 • 12 weeks of trial or participants length of participation
|
|
General disorders
intoxication
|
3.3%
2/61 • Number of events 2 • 12 weeks of trial or participants length of participation
|
21.3%
13/61 • Number of events 13 • 12 weeks of trial or participants length of participation
|
|
General disorders
headache
|
19.7%
12/61 • Number of events 12 • 12 weeks of trial or participants length of participation
|
16.4%
10/61 • Number of events 10 • 12 weeks of trial or participants length of participation
|
|
Psychiatric disorders
anxiety
|
18.0%
11/61 • Number of events 11 • 12 weeks of trial or participants length of participation
|
4.9%
3/61 • Number of events 3 • 12 weeks of trial or participants length of participation
|
|
Vascular disorders
hypotension
|
1.6%
1/61 • Number of events 1 • 12 weeks of trial or participants length of participation
|
16.4%
10/61 • Number of events 10 • 12 weeks of trial or participants length of participation
|
|
General disorders
drowsiness
|
6.6%
4/61 • Number of events 4 • 12 weeks of trial or participants length of participation
|
14.8%
9/61 • Number of events 9 • 12 weeks of trial or participants length of participation
|
|
Respiratory, thoracic and mediastinal disorders
upper respiratory infection
|
13.1%
8/61 • Number of events 8 • 12 weeks of trial or participants length of participation
|
3.3%
2/61 • Number of events 2 • 12 weeks of trial or participants length of participation
|
|
Gastrointestinal disorders
nausea
|
8.2%
5/61 • Number of events 5 • 12 weeks of trial or participants length of participation
|
9.8%
6/61 • Number of events 6 • 12 weeks of trial or participants length of participation
|
|
General disorders
irritability
|
9.8%
6/61 • Number of events 6 • 12 weeks of trial or participants length of participation
|
4.9%
3/61 • Number of events 3 • 12 weeks of trial or participants length of participation
|
|
Metabolism and nutrition disorders
decreased appetite
|
9.8%
6/61 • Number of events 6 • 12 weeks of trial or participants length of participation
|
3.3%
2/61 • Number of events 2 • 12 weeks of trial or participants length of participation
|
|
Skin and subcutaneous tissue disorders
sweating
|
8.2%
5/61 • Number of events 5 • 12 weeks of trial or participants length of participation
|
8.2%
5/61 • Number of events 5 • 12 weeks of trial or participants length of participation
|
|
Psychiatric disorders
depression
|
8.2%
5/61 • Number of events 5 • 12 weeks of trial or participants length of participation
|
4.9%
3/61 • Number of events 3 • 12 weeks of trial or participants length of participation
|
|
Gastrointestinal disorders
stomache upset
|
8.2%
5/61 • Number of events 5 • 12 weeks of trial or participants length of participation
|
3.3%
2/61 • Number of events 2 • 12 weeks of trial or participants length of participation
|
|
Gastrointestinal disorders
diarrhea
|
6.6%
4/61 • Number of events 4 • 12 weeks of trial or participants length of participation
|
3.3%
2/61 • Number of events 2 • 12 weeks of trial or participants length of participation
|
|
Gastrointestinal disorders
vomitting
|
6.6%
4/61 • Number of events 4 • 12 weeks of trial or participants length of participation
|
3.3%
2/61 • Number of events 2 • 12 weeks of trial or participants length of participation
|
|
General disorders
fever
|
6.6%
4/61 • Number of events 4 • 12 weeks of trial or participants length of participation
|
1.6%
1/61 • Number of events 1 • 12 weeks of trial or participants length of participation
|
|
Vascular disorders
orthostasis
|
1.6%
1/61 • Number of events 1 • 12 weeks of trial or participants length of participation
|
6.6%
4/61 • Number of events 4 • 12 weeks of trial or participants length of participation
|
|
General disorders
sore throat
|
4.9%
3/61 • Number of events 3 • 12 weeks of trial or participants length of participation
|
3.3%
2/61 • Number of events 2 • 12 weeks of trial or participants length of participation
|
|
Gastrointestinal disorders
gas
|
1.6%
1/61 • Number of events 1 • 12 weeks of trial or participants length of participation
|
4.9%
3/61 • Number of events 3 • 12 weeks of trial or participants length of participation
|
|
Nervous system disorders
confusion
|
1.6%
1/61 • Number of events 1 • 12 weeks of trial or participants length of participation
|
4.9%
3/61 • Number of events 3 • 12 weeks of trial or participants length of participation
|
|
Skin and subcutaneous tissue disorders
rash
|
4.9%
3/61 • Number of events 3 • 12 weeks of trial or participants length of participation
|
0.00%
0/61 • 12 weeks of trial or participants length of participation
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place