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| ID | Type | Description | Link |
|---|---|---|---|
| R01DA015451 | 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 determine if Venlafaxine Extended Release (Ven-XR) is effective in treating individuals with marijuana addiction and depression.
Given that depression and marijuana addiction often occur together, medications to treat individuals diagnosed with both conditions may be effective. The purpose of this study is to determine the effectiveness of Ven-XR in treating individuals diagnosed with depression and marijuana addiction.
During this twelve-week, double-blind, placebo-controlled study, study visits will occur twice each week. During study visits, participants will receive either placebo or medication and provide a urine sample for drug screening. Blood tests will be collected each month and women must take pregnancy tests each month. Throughout the study, all participants will receive individualized psychotherapy sessions. At each study visit, participants will be given $5 to cover transportation costs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Venlafaxine | Active Comparator | Venlafaxine |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Venlafaxine | Drug | 375mg/day |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Two Consecutive Weeks of Marijuana Abstinence | The primary outcome measure for marijuana use was a dichotomous abstinence response,defined as at least two consecutive urine-confirmed abstinent weeks. Each week during the study, subjects were scored as urine-confirmed abstinent if both self-reported marijuana use for that week was negative, according to the quantitative substance use daily inventory (Timeline FollowBack), and all urines collected for that week were negative for THC. Patients who achieved the two consecutive abstinent weeks were classified as abstinent whether or not they subsequently dropped out of the study. Patients who dropped out of the study without achieving two continuous weeks of abstinence were classified as not abstinent. | measured daily by self report for 12 weeks of the trial or length of study participation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frances R Levin, M.D. | New York State Psychiatric Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York State Psychiatric Institute | New York | New York | 10032 | United States |
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| Label | URL |
|---|---|
| Click here for the Substance Treatment and Research Service website | View source |
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The trial included a one-week placebo lead-in. Placebo responders during the placebo lead in (N = 7), defined as a Clinical Global Impression rating of 1 or 2 and a reduction in the Hamilton Depression score > 75% or total score ≤ 7, were not randomized. Additionally, 13 participants were lost to follow-up so a total of 103 were randomized.
The study was conducted from January 2004 through September 2010. Treatment seekers for problems related to marijuana use were recruited by local advertising or clinical referrals. Participants were treated at Columbia University/New York State Psychiatric Institute or at Columbia University/North Shore-LIJ Medical Center.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Matched Placebo |
| FG001 | Venlafaxine | Venlafaxine: VEN-XR was titrated to the target dose of 225 mg/day (or the maximum tolerated dose) over the three weeks after randomization. After the fourth week post-randomization, patients with persistent depression who were not rated as having a CGI-Depression score of 1 ("very much improved') and who were tolerating 225 mg/day had their dose increased to a maximum of 375 mg/day. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Matched Placebo |
| BG001 | Venlafaxine | Venlafaxine: VEN-XR was titrated to the target dose of 225 mg/day (or the maximum tolerated dose) over the three weeks after randomization. After the fourth week post-randomization, patients with persistent depression who were not rated as having a CGI-Depression score of 1 ("very much improved') and who were tolerating 225 mg/day had their dose increased to a maximum of 375 mg/day. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Two Consecutive Weeks of Marijuana Abstinence | The primary outcome measure for marijuana use was a dichotomous abstinence response,defined as at least two consecutive urine-confirmed abstinent weeks. Each week during the study, subjects were scored as urine-confirmed abstinent if both self-reported marijuana use for that week was negative, according to the quantitative substance use daily inventory (Timeline FollowBack), and all urines collected for that week were negative for THC. Patients who achieved the two consecutive abstinent weeks were classified as abstinent whether or not they subsequently dropped out of the study. Patients who dropped out of the study without achieving two continuous weeks of abstinence were classified as not abstinent. | All analyses were conducted based on the intent-to-treat principle. | Posted | Number | participants | measured daily by self report for 12 weeks of the trial or length of study participation |
|
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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 | Placebo | Matched Placebo |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| anxiety | Psychiatric disorders | Systematic Assessment |
This was an outpatient study and excluded patients with very severe depression. Thus we cannot generalize the findings to individuals with more severe depressive symptoms. The study length was relatively brief.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Frances R. Levin | Columbia University | 212-543-5896 | frl2@columbia.edu |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D002189 | Marijuana Abuse |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
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| ID | Term |
|---|---|
| D000069470 | Venlafaxine Hydrochloride |
| ID | Term |
|---|---|
| D003511 | Cyclohexanols |
| D000441 | Hexanols |
| D005233 | Fatty Alcohols |
| D000438 | Alcohols |
| D009930 |
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| Placebo |
| Drug |
Placebo |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Matched Placebo |
| OG001 | Venlafaxine | Venlafaxine: VEN-XR was titrated to the target dose of 225 mg/day (or the maximum tolerated dose) over the three weeks after randomization. After the fourth week post-randomization, patients with persistent depression who were not rated as having a CGI-Depression score of 1 ("very much improved') and who were tolerating 225 mg/day had their dose increased to a maximum of 375 mg/day. |
|
|
|
| 0 |
| 52 |
| 24 |
| 52 |
| EG001 | Venlafaxine | Venlafaxine: VEN-XR was titrated to the target dose of 225 mg/day (or the maximum tolerated dose) over the three weeks after randomization. After the fourth week post-randomization, patients with persistent depression who were not rated as having a CGI-Depression score of 1 ("very much improved') and who were tolerating 225 mg/day had their dose increased to a maximum of 375 mg/day. | 0 | 51 | 33 | 51 |
| diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| dizziness | General disorders | Systematic Assessment |
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| fatigue | General disorders | Systematic Assessment |
|
| GI Upset | Gastrointestinal disorders | Systematic Assessment |
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| headache | General disorders | Systematic Assessment |
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| insomnia | General disorders | Systematic Assessment |
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| loss of libido | General disorders | Systematic Assessment |
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| muscle aches | General disorders | Systematic Assessment |
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| nausea | Gastrointestinal disorders | Systematic Assessment |
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| syncopy or light headedness | General disorders | Systematic Assessment |
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| D001523 |
| Mental Disorders |
| Organic Chemicals |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000588 | Amines |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D008055 | Lipids |