rimonabant
double blind, placebo controlled, single 90 mg dose
CB1 receptor antagonistLoading study record…
Loading study record…
The purpose of this study is to find out more about cognitive functioning in people who are cannabis dependent, relative to people who do not use cannabis, and how their brains process information after one month of not using cannabis. An additional goal is to characterize the severity of cannabis dependence using precipitated and naturalistic withdrawal with a double blind, placebo controlled, single administration of rimonabant. Research assessments occur bi-weekly throughout this 28 day study.
Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2017-06-19
What this record can show
Results are reported by the registry submitter and preserved exactly. They are not independent verification or a treatment recommendation.
Registry facts
Linked local records
Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.
Interventions
double blind, placebo controlled, single 90 mg dose
CB1 receptor antagonistmatched placebo
Source-reported results
Results are reported by the registry submitter and preserved exactly. They are not independent verification or a treatment recommendation.
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.
Population: 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.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Rimonabant | 21 | 6.62 | 5.59 |
| Placebo | 19 | 6.68 | 7.87 |
| Control | 19 | 1.05 | 2.39 |
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.
Eligibility
primary outcomes
Time frame: 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.
Time frame: Day 28
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.
Time frame: Day 28
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.
Time frame: Day 0 and Day 28
The 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.
Time frame: Day 0 and Day 28
The 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.
Publications
No exact PMID-linked public article is currently readable locally.
Population: 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.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Rimonabant | 21 | 2.12 | 1.14 |
| Placebo | 19 | 2.04 | 1.05 |
| Control | 15 | 1.75 | 0.84 |
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.
Population: 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.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Rimonabant | 21 | 27.36 | 15.03 |
| Placebo | 18 | 19.29 | 7.42 |
| Control | 18 | 22.72 | 15.21 |
The 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.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Rimonabant | 21 | -2.67 | 4.15 |
| Placebo | 19 | -1.37 | 5.16 |
| Control | 20 | -1.50 | 3.62 |
The 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.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Rimonabant | 21 | -10.62 | 13.46 |
| Placebo | 19 | -1.95 | 11.43 |
| Control | 20 | -2.85 | 9.36 |
The 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.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Rimonabant | 21 | -139.80 | 414.68 |
| Placebo | 19 | 420.24 | 2262.39 |
| Control | 20 | 22.01 | 1438.16 |
| Milestone | Rimonabant | Placebo | Control |
|---|---|---|---|
| STARTED | 23 | 23 | 20 |
| COMPLETED | 21 | 19 | 20 |
| NOT COMPLETED | 2 | 4 | 0 |
| Event | System | Groups: affected / at risk |
|---|---|---|
| Dyspepsia | Gastrointestinal disorders | Rimonabant: 2 / 23 · Placebo: 0 / 23 · Control: 0 / 20 |
| Nausea | Gastrointestinal disorders | Rimonabant: 4 / 23 · Placebo: 1 / 23 · Control: 0 / 20 |
| Fatigue | General disorders | Rimonabant: 2 / 23 · Placebo: 0 / 23 · Control: 0 / 20 |
| Nasopharyngitis | Infections and infestations | Rimonabant: 0 / 23 · Placebo: 5 / 23 · Control: 2 / 20 |
| Decreased appetite | Metabolism and nutrition disorders | Rimonabant: 4 / 23 · Placebo: 0 / 23 · Control: 0 / 20 |
| Back pain | Musculoskeletal and connective tissue disorders | Rimonabant: 3 / 23 · Placebo: 2 / 23 · Control: 0 / 20 |
| Headache | Nervous system disorders | Rimonabant: 5 / 23 · Placebo: 3 / 23 · Control: 2 / 20 |
Time frame: Day 0 and Day 28
The 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.