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| ID | Type | Description | Link |
|---|---|---|---|
| P20DA024194 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cannabis-dependent rimonabant | Experimental | Cannabis dependent young adults administered rimonabant 90 mg at Day 0 and followed for 28 days post. |
|
| Cannabis-dependent placebo | Placebo Comparator | Cannabis dependent young adults administered matched placebo at Day 0 and followed for 28 days post. |
|
| Non-cannabis using control | No Intervention | Non-cannabis using demographically similar young adults followed for 28 days. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rimonabant | Drug | double blind, placebo controlled, single 90 mg dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. | Day 28 |
| Plasma Norepinephrine | 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. | Day 28 |
| Plasma Cortisol | 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. | Day 28 |
| Change From Day 0 in Performance on the Cambridge Neuropsychological Test Automated Batteries Spatial Working Memory (CANTAB SWM) Strategy Score at 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. | Day 0 and Day 28 |
| Change From Day 0 in Performance on the Cambridge Neuropsychological Test Automated Batteries Spatial Working Memory (CANTAB SWM) Total Errors at Day 28 |
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Cannabis Dependent Subjects:
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Barbara J Mason, Ph.D. | The Scripps Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Scripps Research Institute | La Jolla | California | 92037 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Rimonabant | Participants were cannabis dependent and received a single 90 mg dose of rimonabant at baseline visit. |
| FG001 | Placebo | Participants were cannabis dependent and received matched placebo. |
| FG002 | Control | Participants were non-cannabis using controls. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Per study design specifying that non-completers would be replaced to yield n=60 completers, two enrolled participants in the rimonabant group and four enrolled participants in the placebo group were not included in baseline (or additional) analyses.
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| ID | Title | Description |
|---|---|---|
| BG000 | Rimonabant | Participants were cannabis dependent and received a single 90 mg dose of rimonabant at baseline visit. |
| BG001 | Placebo | Participants were cannabis dependent and received matched placebo. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Day 28 |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Rimonabant | Participants were cannabis dependent and received a single 90 mg dose of rimonabant at baseline visit. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dyspepsia | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Barbara Mason | The Scripps Research Institute | (858) 784-7324 | mason@scripps.edu |
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| ID | Term |
|---|---|
| D002189 | Marijuana Abuse |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000077285 | Rimonabant |
| ID | Term |
|---|---|
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| placebo | Drug | matched placebo |
|
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. |
| Day 0 and Day 28 |
| 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 | 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. | Day 0 and Day 28 |
| BG002 | Control | Participants were non-cannabis using controls. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Participants were cannabis dependent and received a single 90 mg dose of rimonabant at baseline visit.
| OG001 | Placebo | Participants were cannabis dependent and received matched placebo. |
| OG002 | Control | Participants were non-cannabis using controls. |
|
|
| Primary | Plasma Norepinephrine | 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. | 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. | Posted | Mean | Standard Deviation | ng/mL | Day 28 |
|
|
|
| Primary | Plasma Cortisol | 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. | 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. | Posted | Mean | Standard Deviation | ug/dL | Day 28 |
|
|
|
| Primary | Change From Day 0 in Performance on the Cambridge Neuropsychological Test Automated Batteries Spatial Working Memory (CANTAB SWM) Strategy Score at 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. | Posted | Mean | Standard Deviation | units on a scale | Day 0 and Day 28 |
|
|
|
| Primary | Change From Day 0 in Performance on the Cambridge Neuropsychological Test Automated Batteries Spatial Working Memory (CANTAB SWM) Total Errors at 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. | Posted | Mean | Standard Deviation | units on a scale | Day 0 and Day 28 |
|
|
|
| Primary | 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 | 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. | Posted | Mean | Standard Deviation | milliseconds | Day 0 and Day 28 |
|
|
|
| 0 |
| 23 |
| 10 |
| 23 |
| EG001 | Placebo | Participants were cannabis dependent and received matched placebo. | 0 | 23 | 10 | 23 |
| EG002 | Control | Participants were non-cannabis using controls. | 0 | 20 | 4 | 20 |
| Nausea | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (19.1) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
|
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| D010880 |
| Piperidines |