Trial Outcomes & Findings for Clinical and Neurobiological Effects of Cannabis Dependence in Young Adults (NCT NCT00656487)
NCT ID: NCT00656487
Last Updated: 2017-06-19
Results Overview
The MWC is a 28-item instrument that is used to assess the severity of frequently reported cannabis withdrawal symptoms. Each item on the measure is recorded as a severity rating between 0-3 where a zero indicates not present and a three indicates severe. The severity rating of each item was summed to obtain a single marijuana withdrawal severity score ranging between 0- 84. A lower score indicates less severe withdrawal.
COMPLETED
PHASE2
66 participants
Day 28
2017-06-19
Participant Flow
Participant milestones
| Measure |
Rimonabant
Participants were cannabis dependent and received a single 90 mg dose of rimonabant at baseline visit.
|
Placebo
Participants were cannabis dependent and received matched placebo.
|
Control
Participants were non-cannabis using controls.
|
|---|---|---|---|
|
Overall Study
STARTED
|
23
|
23
|
20
|
|
Overall Study
COMPLETED
|
21
|
19
|
20
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Clinical and Neurobiological Effects of Cannabis Dependence in Young Adults
Baseline characteristics by cohort
| Measure |
Rimonabant
n=21 Participants
Participants were cannabis dependent and received a single 90 mg dose of rimonabant at baseline visit.
|
Placebo
n=19 Participants
Participants were cannabis dependent and received matched placebo.
|
Control
n=20 Participants
Participants were non-cannabis using controls.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
22.33 years
STANDARD_DEVIATION 1.53 • n=5 Participants
|
23.53 years
STANDARD_DEVIATION 2.76 • n=7 Participants
|
24.15 years
STANDARD_DEVIATION 2.83 • n=5 Participants
|
23.32 years
STANDARD_DEVIATION 2.51 • n=4 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
41 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Day 28Population: One participant in the control group who completed monitoring during the double-blind portion of the trial did not complete a Marijuana Withdrawal Checklist at Day 28.
The MWC is a 28-item instrument that is used to assess the severity of frequently reported cannabis withdrawal symptoms. Each item on the measure is recorded as a severity rating between 0-3 where a zero indicates not present and a three indicates severe. The severity rating of each item was summed to obtain a single marijuana withdrawal severity score ranging between 0- 84. A lower score indicates less severe withdrawal.
Outcome measures
| Measure |
Rimonabant
n=21 Participants
Participants were cannabis dependent and received a single 90 mg dose of rimonabant at baseline visit.
|
Placebo
n=19 Participants
Participants were cannabis dependent and received matched placebo.
|
Control
n=19 Participants
Participants were non-cannabis using controls.
|
|---|---|---|---|
|
Withdrawal Symptom Severity on the Marijuana Withdrawal Checklist (MWC) at 28 Days Following Single Dose Administration of Rimonabant or Placebo, or Commencement of Monitoring, During the Double-Blind Period
|
6.62 units on a scale
Standard Deviation 5.59
|
6.68 units on a scale
Standard Deviation 7.87
|
1.05 units on a scale
Standard Deviation 2.39
|
PRIMARY outcome
Timeframe: Day 28Population: Five control participants who completed the double blind / monitoring portion of the trial did not have samples available for analysis at Day 28. Two participants did not have blood drawn; two additional participant sample results were not returned by the laboratory; and one participant did not return a result due to an ELISA kit error.
Blood samples were obtained and plasma concentrations were determined using validated enzyme-linked immunosorbent assay (ELISA) techniques at 28 days following single dose administration of rimonabant or placebo, or commencement of monitoring, during the double-blind period.
Outcome measures
| Measure |
Rimonabant
n=21 Participants
Participants were cannabis dependent and received a single 90 mg dose of rimonabant at baseline visit.
|
Placebo
n=19 Participants
Participants were cannabis dependent and received matched placebo.
|
Control
n=15 Participants
Participants were non-cannabis using controls.
|
|---|---|---|---|
|
Plasma Norepinephrine
|
2.12 ng/mL
Standard Deviation 1.14
|
2.04 ng/mL
Standard Deviation 1.05
|
1.75 ng/mL
Standard Deviation 0.84
|
PRIMARY outcome
Timeframe: Day 28Population: Two control participants and one placebo participant who completed the double blind / monitoring portion of the trial did not have samples available for analysis at Day 28. The control participants did not have blood drawn; the placebo participant returned a non-detectable value.
Blood samples were obtained and plasma concentrations were determined using validated enzyme-linked immunosorbent assay (ELISA) techniques at 28 days following single dose administration of rimonabant or placebo, or commencement of monitoring, during the double-blind period.
Outcome measures
| Measure |
Rimonabant
n=21 Participants
Participants were cannabis dependent and received a single 90 mg dose of rimonabant at baseline visit.
|
Placebo
n=18 Participants
Participants were cannabis dependent and received matched placebo.
|
Control
n=18 Participants
Participants were non-cannabis using controls.
|
|---|---|---|---|
|
Plasma Cortisol
|
27.36 ug/dL
Standard Deviation 15.03
|
19.29 ug/dL
Standard Deviation 7.42
|
22.72 ug/dL
Standard Deviation 15.21
|
PRIMARY outcome
Timeframe: Day 0 and Day 28The CANTAB SWM task is a validated computer-based testing instrument assessing the memory component of executive function. Strategy Score is an estimate of use of the most efficient strategy to complete the task. Scores range from 8-56; higher scores equate to poor use of the most efficient strategy. Change = (Day 28 Score - Day 0 Score). A more negative result indicates greater improvement.
Outcome measures
| Measure |
Rimonabant
n=21 Participants
Participants were cannabis dependent and received a single 90 mg dose of rimonabant at baseline visit.
|
Placebo
n=19 Participants
Participants were cannabis dependent and received matched placebo.
|
Control
n=20 Participants
Participants were non-cannabis using controls.
|
|---|---|---|---|
|
Change From Day 0 in Performance on the Cambridge Neuropsychological Test Automated Batteries Spatial Working Memory (CANTAB SWM) Strategy Score at Day 28
|
-2.67 units on a scale
Standard Deviation 4.15
|
-1.37 units on a scale
Standard Deviation 5.16
|
-1.50 units on a scale
Standard Deviation 3.62
|
PRIMARY outcome
Timeframe: Day 0 and Day 28The CANTAB SWM task is a validated computer-based testing instrument assessing the memory component of executive function. Total Errors are a measure of performance and are unbounded. Change = (Day 28 Score - Day 0 Score). A more negative result indicates greater improvement.
Outcome measures
| Measure |
Rimonabant
n=21 Participants
Participants were cannabis dependent and received a single 90 mg dose of rimonabant at baseline visit.
|
Placebo
n=19 Participants
Participants were cannabis dependent and received matched placebo.
|
Control
n=20 Participants
Participants were non-cannabis using controls.
|
|---|---|---|---|
|
Change From Day 0 in Performance on the Cambridge Neuropsychological Test Automated Batteries Spatial Working Memory (CANTAB SWM) Total Errors at Day 28
|
-10.62 units on a scale
Standard Deviation 13.46
|
-1.95 units on a scale
Standard Deviation 11.43
|
-2.85 units on a scale
Standard Deviation 9.36
|
PRIMARY outcome
Timeframe: Day 0 and Day 28The CANTAB SWM task is a validated computer-based testing instrument assessing the memory component of executive function. Mean Time To First Response is a measure of latency and is unbounded. Change = (Day 28 Time - Day 0 Time). A more negative result indicates greater improvement.
Outcome measures
| Measure |
Rimonabant
n=21 Participants
Participants were cannabis dependent and received a single 90 mg dose of rimonabant at baseline visit.
|
Placebo
n=19 Participants
Participants were cannabis dependent and received matched placebo.
|
Control
n=20 Participants
Participants were non-cannabis using controls.
|
|---|---|---|---|
|
Change From Day 0 in Performance on the Cambridge Neuropsychological Test Automated Batteries Spatial Working Memory (CANTAB SWM) Mean Time To First Response at Day 28
|
-139.80 milliseconds
Standard Deviation 414.68
|
420.24 milliseconds
Standard Deviation 2262.39
|
22.01 milliseconds
Standard Deviation 1438.16
|
Adverse Events
Rimonabant
Placebo
Control
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Rimonabant
n=23 participants at risk
Participants were cannabis dependent and received a single 90 mg dose of rimonabant at baseline visit.
|
Placebo
n=23 participants at risk
Participants were cannabis dependent and received matched placebo.
|
Control
n=20 participants at risk
Participants were non-cannabis using controls.
|
|---|---|---|---|
|
Gastrointestinal disorders
Dyspepsia
|
8.7%
2/23 • Adverse event data was collected at all ten study visits, an average duration of 28 days.
Adverse events, both serious and other, were documented at all ten study visits by the Medical Assistant on the adverse experiences case report form.
|
0.00%
0/23 • Adverse event data was collected at all ten study visits, an average duration of 28 days.
Adverse events, both serious and other, were documented at all ten study visits by the Medical Assistant on the adverse experiences case report form.
|
0.00%
0/20 • Adverse event data was collected at all ten study visits, an average duration of 28 days.
Adverse events, both serious and other, were documented at all ten study visits by the Medical Assistant on the adverse experiences case report form.
|
|
Gastrointestinal disorders
Nausea
|
17.4%
4/23 • Adverse event data was collected at all ten study visits, an average duration of 28 days.
Adverse events, both serious and other, were documented at all ten study visits by the Medical Assistant on the adverse experiences case report form.
|
4.3%
1/23 • Adverse event data was collected at all ten study visits, an average duration of 28 days.
Adverse events, both serious and other, were documented at all ten study visits by the Medical Assistant on the adverse experiences case report form.
|
0.00%
0/20 • Adverse event data was collected at all ten study visits, an average duration of 28 days.
Adverse events, both serious and other, were documented at all ten study visits by the Medical Assistant on the adverse experiences case report form.
|
|
General disorders
Fatigue
|
8.7%
2/23 • Adverse event data was collected at all ten study visits, an average duration of 28 days.
Adverse events, both serious and other, were documented at all ten study visits by the Medical Assistant on the adverse experiences case report form.
|
0.00%
0/23 • Adverse event data was collected at all ten study visits, an average duration of 28 days.
Adverse events, both serious and other, were documented at all ten study visits by the Medical Assistant on the adverse experiences case report form.
|
0.00%
0/20 • Adverse event data was collected at all ten study visits, an average duration of 28 days.
Adverse events, both serious and other, were documented at all ten study visits by the Medical Assistant on the adverse experiences case report form.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/23 • Adverse event data was collected at all ten study visits, an average duration of 28 days.
Adverse events, both serious and other, were documented at all ten study visits by the Medical Assistant on the adverse experiences case report form.
|
21.7%
5/23 • Adverse event data was collected at all ten study visits, an average duration of 28 days.
Adverse events, both serious and other, were documented at all ten study visits by the Medical Assistant on the adverse experiences case report form.
|
10.0%
2/20 • Adverse event data was collected at all ten study visits, an average duration of 28 days.
Adverse events, both serious and other, were documented at all ten study visits by the Medical Assistant on the adverse experiences case report form.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
17.4%
4/23 • Adverse event data was collected at all ten study visits, an average duration of 28 days.
Adverse events, both serious and other, were documented at all ten study visits by the Medical Assistant on the adverse experiences case report form.
|
0.00%
0/23 • Adverse event data was collected at all ten study visits, an average duration of 28 days.
Adverse events, both serious and other, were documented at all ten study visits by the Medical Assistant on the adverse experiences case report form.
|
0.00%
0/20 • Adverse event data was collected at all ten study visits, an average duration of 28 days.
Adverse events, both serious and other, were documented at all ten study visits by the Medical Assistant on the adverse experiences case report form.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
13.0%
3/23 • Adverse event data was collected at all ten study visits, an average duration of 28 days.
Adverse events, both serious and other, were documented at all ten study visits by the Medical Assistant on the adverse experiences case report form.
|
8.7%
2/23 • Adverse event data was collected at all ten study visits, an average duration of 28 days.
Adverse events, both serious and other, were documented at all ten study visits by the Medical Assistant on the adverse experiences case report form.
|
0.00%
0/20 • Adverse event data was collected at all ten study visits, an average duration of 28 days.
Adverse events, both serious and other, were documented at all ten study visits by the Medical Assistant on the adverse experiences case report form.
|
|
Nervous system disorders
Headache
|
21.7%
5/23 • Adverse event data was collected at all ten study visits, an average duration of 28 days.
Adverse events, both serious and other, were documented at all ten study visits by the Medical Assistant on the adverse experiences case report form.
|
13.0%
3/23 • Adverse event data was collected at all ten study visits, an average duration of 28 days.
Adverse events, both serious and other, were documented at all ten study visits by the Medical Assistant on the adverse experiences case report form.
|
10.0%
2/20 • Adverse event data was collected at all ten study visits, an average duration of 28 days.
Adverse events, both serious and other, were documented at all ten study visits by the Medical Assistant on the adverse experiences case report form.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place