Trial Outcomes & Findings for Effect of Clonazepam on Cannabis Withdrawal and Relapse in Treatment-seeking Patients (NCT NCT02913924)
NCT ID: NCT02913924
Last Updated: 2021-08-06
Results Overview
for inpatient participants the number of days till relapse to cannabis use, post inpatient discharge, as recorded on the time line follow-back and confirmed by urine toxicology.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
68 participants
Primary outcome timeframe
Number of days during 12 weeks of study participation
Results posted on
2021-08-06
Participant Flow
Participant milestones
| Measure |
Clonazepam
Clonazepam will be taken twice per day in the morning and in the evening. Clonazepam is given in a "fixed flexible" dose schedule with the dose titrated to 2mg per day or the maximum tolerated dose. Clonazepam will be taken for the first 8 weeks of the trial.
Clonazepam: fixed-flexible daily dose to a maximum of 2 mg (1 mg twice per day) for the first 8 weeks of the trial
|
Placebo
Placebo will be taken twice per day in the morning and in the evening. Placebo will be taken for the first 8 weeks of the trial.
Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
34
|
34
|
|
Overall Study
COMPLETED
|
21
|
21
|
|
Overall Study
NOT COMPLETED
|
13
|
13
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Clonazepam on Cannabis Withdrawal and Relapse in Treatment-seeking Patients
Baseline characteristics by cohort
| Measure |
Clonazepam
n=34 Participants
Clonazepam will be taken twice per day in the morning and in the evening. Clonazepam is given in a "fixed flexible" dose schedule with the dose titrated to 2mg per day or the maximum tolerated dose. Clonazepam will be taken for the first 8 weeks of the trial.
Clonazepam: fixed-flexible daily dose to a maximum of 2 mg (1 mg twice per day) for the first 8 weeks of the trial
|
Placebo
n=34 Participants
Placebo will be taken twice per day in the morning and in the evening. Placebo will be taken for the first 8 weeks of the trial.
Placebo
|
Total
n=68 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
34.9 years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
35.9 years
STANDARD_DEVIATION 12.0 • n=7 Participants
|
35.4 years
STANDARD_DEVIATION 11.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
14 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
13 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
34 participants
n=5 Participants
|
34 participants
n=7 Participants
|
68 participants
n=5 Participants
|
|
Marijuana Using days in prior 28 days at study start
|
27.4 days
STANDARD_DEVIATION 1.5 • n=5 Participants
|
27.2 days
STANDARD_DEVIATION 1.5 • n=7 Participants
|
27.3 days
STANDARD_DEVIATION 1.5 • n=5 Participants
|
PRIMARY outcome
Timeframe: Number of days during 12 weeks of study participationPopulation: 11 participants started the study utilizing the inpatient approach
for inpatient participants the number of days till relapse to cannabis use, post inpatient discharge, as recorded on the time line follow-back and confirmed by urine toxicology.
Outcome measures
| Measure |
Clonazepam
n=6 Participants
Clonazepam will be taken twice per day in the morning and in the evening. Clonazepam is given in a "fixed flexible" dose schedule with the dose titrated to 2mg per day or the maximum tolerated dose. Clonazepam will be taken for the first 8 weeks of the trial.
Clonazepam: fixed-flexible daily dose to a maximum of 2 mg (1 mg twice per day) for the first 8 weeks of the trial
|
Placebo
n=5 Participants
Placebo will be taken twice per day in the morning and in the evening. Placebo will be taken for the first 8 weeks of the trial.
Placebo
|
|---|---|---|
|
Time to Cannabis Use Relapse
|
1 days
Interval 0.0 to 1.0
|
1 days
Interval 0.0 to 39.0
|
PRIMARY outcome
Timeframe: the 7 weeks of study participation or length of participants participation during the medication maintenance phasefor outpatient participants the proportion of cannabis use days per week as recorded by the Timeline Followback method
Outcome measures
| Measure |
Clonazepam
n=28 Participants
Clonazepam will be taken twice per day in the morning and in the evening. Clonazepam is given in a "fixed flexible" dose schedule with the dose titrated to 2mg per day or the maximum tolerated dose. Clonazepam will be taken for the first 8 weeks of the trial.
Clonazepam: fixed-flexible daily dose to a maximum of 2 mg (1 mg twice per day) for the first 8 weeks of the trial
|
Placebo
n=29 Participants
Placebo will be taken twice per day in the morning and in the evening. Placebo will be taken for the first 8 weeks of the trial.
Placebo
|
|---|---|---|
|
Proportion of Cannabis Use Days Per Week
week 1
|
0.74 proportion of use days
Standard Deviation 0.44
|
0.79 proportion of use days
Standard Deviation 0.41
|
|
Proportion of Cannabis Use Days Per Week
week 2
|
0.78 proportion of use days
Standard Deviation 0.41
|
0.75 proportion of use days
Standard Deviation 0.44
|
|
Proportion of Cannabis Use Days Per Week
week 3
|
0.71 proportion of use days
Standard Deviation 0.45
|
0.70 proportion of use days
Standard Deviation 0.46
|
|
Proportion of Cannabis Use Days Per Week
week 4
|
0.67 proportion of use days
Standard Deviation 0.47
|
0.64 proportion of use days
Standard Deviation 0.48
|
|
Proportion of Cannabis Use Days Per Week
week 5
|
0.67 proportion of use days
Standard Deviation 0.47
|
0.64 proportion of use days
Standard Deviation 0.48
|
|
Proportion of Cannabis Use Days Per Week
week 6
|
0.58 proportion of use days
Standard Deviation 0.50
|
0.65 proportion of use days
Standard Deviation 0.48
|
|
Proportion of Cannabis Use Days Per Week
week 7
|
0.58 proportion of use days
Standard Deviation 0.50
|
0.67 proportion of use days
Standard Deviation 0.47
|
Adverse Events
Clonazepam
Serious events: 1 serious events
Other events: 27 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Clonazepam
n=34 participants at risk
Clonazepam will be taken twice per day in the morning and in the evening. Clonazepam is given in a "fixed flexible" dose schedule with the dose titrated to 2mg per day or the maximum tolerated dose. Clonazepam will be taken for the first 8 weeks of the trial.
Clonazepam: fixed-flexible daily dose to a maximum of 2 mg (1 mg twice per day) for the first 8 weeks of the trial
|
Placebo
n=34 participants at risk
Placebo will be taken twice per day in the morning and in the evening. Placebo will be taken for the first 8 weeks of the trial.
Placebo
|
|---|---|---|
|
Psychiatric disorders
psychotic episode
|
2.9%
1/34 • Number of events 1 • Length of participant's participation, up to 12 weeks
|
0.00%
0/34 • Length of participant's participation, up to 12 weeks
|
|
Psychiatric disorders
suicidal ideation
|
0.00%
0/34 • Length of participant's participation, up to 12 weeks
|
2.9%
1/34 • Number of events 1 • Length of participant's participation, up to 12 weeks
|
Other adverse events
| Measure |
Clonazepam
n=34 participants at risk
Clonazepam will be taken twice per day in the morning and in the evening. Clonazepam is given in a "fixed flexible" dose schedule with the dose titrated to 2mg per day or the maximum tolerated dose. Clonazepam will be taken for the first 8 weeks of the trial.
Clonazepam: fixed-flexible daily dose to a maximum of 2 mg (1 mg twice per day) for the first 8 weeks of the trial
|
Placebo
n=34 participants at risk
Placebo will be taken twice per day in the morning and in the evening. Placebo will be taken for the first 8 weeks of the trial.
Placebo
|
|---|---|---|
|
General disorders
insomnia
|
5.9%
2/34 • Number of events 2 • Length of participant's participation, up to 12 weeks
|
14.7%
5/34 • Number of events 5 • Length of participant's participation, up to 12 weeks
|
|
Psychiatric disorders
depression
|
5.9%
2/34 • Number of events 2 • Length of participant's participation, up to 12 weeks
|
8.8%
3/34 • Number of events 3 • Length of participant's participation, up to 12 weeks
|
|
General disorders
sedation
|
29.4%
10/34 • Number of events 10 • Length of participant's participation, up to 12 weeks
|
0.00%
0/34 • Length of participant's participation, up to 12 weeks
|
|
Psychiatric disorders
anxiety
|
2.9%
1/34 • Number of events 1 • Length of participant's participation, up to 12 weeks
|
8.8%
3/34 • Number of events 3 • Length of participant's participation, up to 12 weeks
|
|
Gastrointestinal disorders
nausea
|
8.8%
3/34 • Number of events 3 • Length of participant's participation, up to 12 weeks
|
5.9%
2/34 • Number of events 2 • Length of participant's participation, up to 12 weeks
|
|
General disorders
concentration issues
|
5.9%
2/34 • Number of events 2 • Length of participant's participation, up to 12 weeks
|
0.00%
0/34 • Length of participant's participation, up to 12 weeks
|
|
General disorders
dizziness
|
14.7%
5/34 • Number of events 5 • Length of participant's participation, up to 12 weeks
|
5.9%
2/34 • Number of events 2 • Length of participant's participation, up to 12 weeks
|
|
General disorders
headache
|
11.8%
4/34 • Number of events 4 • Length of participant's participation, up to 12 weeks
|
11.8%
4/34 • Number of events 4 • Length of participant's participation, up to 12 weeks
|
|
Gastrointestinal disorders
vomiting
|
2.9%
1/34 • Number of events 1 • Length of participant's participation, up to 12 weeks
|
2.9%
1/34 • Number of events 1 • Length of participant's participation, up to 12 weeks
|
|
General disorders
abdominal pain
|
0.00%
0/34 • Length of participant's participation, up to 12 weeks
|
2.9%
1/34 • Number of events 1 • Length of participant's participation, up to 12 weeks
|
|
General disorders
anorexia
|
5.9%
2/34 • Number of events 2 • Length of participant's participation, up to 12 weeks
|
2.9%
1/34 • Number of events 1 • Length of participant's participation, up to 12 weeks
|
|
Gastrointestinal disorders
bowel incontinence
|
2.9%
1/34 • Number of events 1 • Length of participant's participation, up to 12 weeks
|
0.00%
0/34 • Length of participant's participation, up to 12 weeks
|
|
General disorders
dental cavities
|
0.00%
0/34 • Length of participant's participation, up to 12 weeks
|
2.9%
1/34 • Number of events 1 • Length of participant's participation, up to 12 weeks
|
|
General disorders
diminished libido
|
2.9%
1/34 • Number of events 1 • Length of participant's participation, up to 12 weeks
|
0.00%
0/34 • Length of participant's participation, up to 12 weeks
|
|
General disorders
erectile dysfunction
|
2.9%
1/34 • Number of events 1 • Length of participant's participation, up to 12 weeks
|
0.00%
0/34 • Length of participant's participation, up to 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
flu
|
0.00%
0/34 • Length of participant's participation, up to 12 weeks
|
2.9%
1/34 • Number of events 1 • Length of participant's participation, up to 12 weeks
|
|
General disorders
incoordination
|
2.9%
1/34 • Number of events 1 • Length of participant's participation, up to 12 weeks
|
0.00%
0/34 • Length of participant's participation, up to 12 weeks
|
|
General disorders
increased appetite
|
0.00%
0/34 • Length of participant's participation, up to 12 weeks
|
2.9%
1/34 • Number of events 1 • Length of participant's participation, up to 12 weeks
|
|
General disorders
irritability
|
5.9%
2/34 • Number of events 2 • Length of participant's participation, up to 12 weeks
|
5.9%
2/34 • Number of events 2 • Length of participant's participation, up to 12 weeks
|
|
Skin and subcutaneous tissue disorders
itching
|
2.9%
1/34 • Number of events 1 • Length of participant's participation, up to 12 weeks
|
0.00%
0/34 • Length of participant's participation, up to 12 weeks
|
|
Musculoskeletal and connective tissue disorders
knee pain
|
0.00%
0/34 • Length of participant's participation, up to 12 weeks
|
2.9%
1/34 • Number of events 1 • Length of participant's participation, up to 12 weeks
|
|
General disorders
memory
|
11.8%
4/34 • Number of events 4 • Length of participant's participation, up to 12 weeks
|
0.00%
0/34 • Length of participant's participation, up to 12 weeks
|
|
General disorders
nightmares
|
2.9%
1/34 • Number of events 1 • Length of participant's participation, up to 12 weeks
|
2.9%
1/34 • Number of events 1 • Length of participant's participation, up to 12 weeks
|
|
Cardiac disorders
orthostasis
|
2.9%
1/34 • Number of events 1 • Length of participant's participation, up to 12 weeks
|
0.00%
0/34 • Length of participant's participation, up to 12 weeks
|
|
Psychiatric disorders
psychosis
|
2.9%
1/34 • Number of events 1 • Length of participant's participation, up to 12 weeks
|
0.00%
0/34 • Length of participant's participation, up to 12 weeks
|
|
Skin and subcutaneous tissue disorders
rash
|
0.00%
0/34 • Length of participant's participation, up to 12 weeks
|
2.9%
1/34 • Number of events 1 • Length of participant's participation, up to 12 weeks
|
|
Psychiatric disorders
suicidal ideation
|
5.9%
2/34 • Number of events 2 • Length of participant's participation, up to 12 weeks
|
2.9%
1/34 • Number of events 1 • Length of participant's participation, up to 12 weeks
|
|
General disorders
urinary incontinence
|
5.9%
2/34 • Number of events 2 • Length of participant's participation, up to 12 weeks
|
0.00%
0/34 • Length of participant's participation, up to 12 weeks
|
|
General disorders
sensitivity to cannabis
|
5.9%
2/34 • Number of events 2 • Length of participant's participation, up to 12 weeks
|
2.9%
1/34 • Number of events 1 • Length of participant's participation, up to 12 weeks
|
|
General disorders
palpitations
|
2.9%
1/34 • Number of events 1 • Length of participant's participation, up to 12 weeks
|
2.9%
1/34 • Number of events 1 • Length of participant's participation, up to 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
shortness of breath
|
0.00%
0/34 • Length of participant's participation, up to 12 weeks
|
2.9%
1/34 • Number of events 1 • Length of participant's participation, up to 12 weeks
|
|
General disorders
delayed orgasm
|
2.9%
1/34 • Number of events 1 • Length of participant's participation, up to 12 weeks
|
0.00%
0/34 • Length of participant's participation, up to 12 weeks
|
|
Cardiac disorders
elevated blood pressure
|
2.9%
1/34 • Number of events 1 • Length of participant's participation, up to 12 weeks
|
2.9%
1/34 • Number of events 1 • Length of participant's participation, up to 12 weeks
|
|
General disorders
drowsiness
|
17.6%
6/34 • Number of events 6 • Length of participant's participation, up to 12 weeks
|
5.9%
2/34 • Number of events 2 • Length of participant's participation, up to 12 weeks
|
|
Gastrointestinal disorders
GI upset
|
0.00%
0/34 • Length of participant's participation, up to 12 weeks
|
2.9%
1/34 • Number of events 1 • Length of participant's participation, up to 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
upper respiratory infection
|
8.8%
3/34 • Number of events 3 • Length of participant's participation, up to 12 weeks
|
2.9%
1/34 • Number of events 1 • Length of participant's participation, up to 12 weeks
|
|
General disorders
dry mouth
|
0.00%
0/34 • Length of participant's participation, up to 12 weeks
|
2.9%
1/34 • Number of events 1 • Length of participant's participation, up to 12 weeks
|
|
General disorders
backache
|
0.00%
0/34 • Length of participant's participation, up to 12 weeks
|
2.9%
1/34 • Number of events 1 • Length of participant's participation, up to 12 weeks
|
|
Musculoskeletal and connective tissue disorders
chest discomfort
|
0.00%
0/34 • Length of participant's participation, up to 12 weeks
|
2.9%
1/34 • Number of events 1 • Length of participant's participation, up to 12 weeks
|
|
General disorders
fatigue
|
5.9%
2/34 • Number of events 2 • Length of participant's participation, up to 12 weeks
|
2.9%
1/34 • Number of events 1 • Length of participant's participation, up to 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
mucous cyst
|
2.9%
1/34 • Number of events 1 • Length of participant's participation, up to 12 weeks
|
0.00%
0/34 • Length of participant's participation, up to 12 weeks
|
|
Gastrointestinal disorders
heartburn
|
0.00%
0/34 • Length of participant's participation, up to 12 weeks
|
2.9%
1/34 • Number of events 1 • Length of participant's participation, up to 12 weeks
|
|
General disorders
testicular pain
|
2.9%
1/34 • Number of events 1 • Length of participant's participation, up to 12 weeks
|
0.00%
0/34 • Length of participant's participation, up to 12 weeks
|
|
General disorders
confusion
|
2.9%
1/34 • Number of events 1 • Length of participant's participation, up to 12 weeks
|
0.00%
0/34 • Length of participant's participation, up to 12 weeks
|
|
Gastrointestinal disorders
diarrhea
|
2.9%
1/34 • Number of events 1 • Length of participant's participation, up to 12 weeks
|
0.00%
0/34 • Length of participant's participation, up to 12 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place