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| ID | Type | Description | Link |
|---|---|---|---|
| 5P50DA009236 | 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 baclofen dose-dependently decreases marijuana's direct effects and symptoms of marijuana withdrawal and thus decreases marijuana relapse.
Only a small percentage of dependent-marijuana smokers who are seeking treatment for their marijuana use are able to achieve sustained abstinence. The objective of this study is to investigate the interaction between marijuana and the potential treatment medication, baclofen, with the direct goal of using this information to improve marijuana treatment outcome. GABAB agonists such as baclofen have been shown to attenuate the self-administration of cocaine, heroin, alcohol and nicotine (see Cousins et al., 2002; Haney et al., 2006). Baclofen also appears to decrease withdrawal symptoms in heroin and alcohol abusers (Akhondzadeh et al., 2000; Addolorato et al., 2000). The purpose of this study is to determine if baclofen dose-dependently decreases marijuana's direct effects and symptoms of marijuana withdrawal and thus decreases marijuana relapse in our laboratory model. For the purposes of this model, relapse is defined as a return to marijuana use after a period of abstinence. The study will utilize an inpatient/outpatient, counter-balanced design, with each participant maintained on each of three medication conditions for 16 days: placebo and baclofen (60, 90 mg/day). Participants will begin taking capsules during the outpatient phase so that the dose can be incremented up to the maintenance dose prior to the first inpatient day. Further, clinical studies have shown that baclofen is most effective at decreasing cocaine's effects when administered for several weeks. During the inpatient study phases, participants will have the opportunity to self-administer placebo or active marijuana 6 times per day. This study will provide important information of the effect of baclofen as a potential treatment medication for marijuana dependence.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Baclofen 60 mg, Placebo, Baclofen 90 mg | Experimental | Baclofen (60mg/day or 90 mg/day): Packaged medication in size 00 opaque capsules with riboflavin filler. Study capsules (0, 20, 30mg) were administered 3 times per day (0900, 1530, 2200). Marijuana: Participants each received a single marijuana cigarette (provided by the National Institute on Drug Abuse) at each smoking occasion. Marijuana cigarettes were stored frozen in an airtight container and humidified at room temperature for 24 h prior to use. |
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| Baclofen 90 mg, Placebo, Baclofen 60 mg | Experimental | Baclofen (60mg/day or 90 mg/day): Packaged medication in size 00 opaque capsules with riboflavin filler. Study capsules (0, 20, 30mg) were administered 3 times per day (0900, 1530, 2200). Marijuana: Participants each received a single marijuana cigarette (provided by the National Institute on Drug Abuse) at each smoking occasion. Marijuana cigarettes were stored frozen in an airtight container and humidified at room temperature for 24 h prior to use. |
|
| Baclofen 60 mg, Baclofen 90 mg, Placebo | Experimental | Baclofen (60mg/day or 90 mg/day): Packaged medication in size 00 opaque capsules with riboflavin filler. Study capsules (0, 20, 30mg) were administered 3 times per day (0900, 1530, 2200). Marijuana: Participants each received a single marijuana cigarette (provided by the National Institute on Drug Abuse) at each smoking occasion. Marijuana cigarettes were stored frozen in an airtight container and humidified at room temperature for 24 h prior to use. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Baclofen | Drug | Baclofen (60mg/day or 90 mg/day): Packaged medication in size 00 opaque capsules with riboflavin filler. Study capsules (0, 20, 30mg) were administered 3 times per day (0900, 1530, 2200). |
| Measure | Description | Time Frame |
|---|---|---|
| Measure of Relapse: Change in Money Spent Between Baseline and Relapse Phase | This is a measure of marijuana self-administration and relapse since each initial puff costs $7 and is a burden to overcome just to smoke. Over each 3 day period, the puffs chosen by each participant is averaged for a single value. | Days 1-3 (Baseline) and Days 6-8 (Relapse Phase) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Margaret Haney, Ph.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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20521030 | Background | Haney M, Hart CL, Vosburg SK, Comer SD, Reed SC, Cooper ZD, Foltin RW. Effects of baclofen and mirtazapine on a laboratory model of marijuana withdrawal and relapse. Psychopharmacology (Berl). 2010 Aug;211(2):233-44. doi: 10.1007/s00213-010-1888-6. Epub 2010 Jun 3. |
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13 participants were enrolled, but 10 participants were randomized. Three volunteers (1 female, 2 male) dropped out of the study during the marijuana abstinence phase (two were on baclofen and one was on placebo).
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| ID | Title | Description |
|---|---|---|
| FG000 | Baclofen 60 mg, Placebo, Baclofen 90 mg | participants received baclofen (60 mg/day) for 8 days, followed by placebo for 8 days, then baclofen (90mg/day) for 8 days. |
| FG001 | Baclofen 90 mg, Placebo, Baclofen 60 mg | participants received baclofen (90mg/day) for 8 days, followed by placebo for 8 days, then baclofen (60mg/day) for 8 days. |
| FG002 | Baclofen 60 mg, Baclofen 90 mg, Placebo | participants received baclofen (60mg/day) for 8 days, followed by baclofen (90mg/day) for 8 days, then placebo for 8 days. |
| FG003 | Baclofen 90 mg, Baclofen 60 mg, Placebo | participants received baclofen (90mg/day) for 8 days, followed by baclofen (60mg/day) for 8 days, and then placebo for 8 days. |
| FG004 | Placebo, Baclofen 90 mg, Baclofen 60 mg | participants received placebo for 8 days, followed by baclofen (90mg/day) for 8 days, then baclofen (60mg/day) for 8 days. |
| FG005 | Placebo, Baclofen 60 mg, Baclofen 90 mg | participants received placebo for 8 days, followed by baclofen (60mg/day) for 8 days, then baclofen (90mg/day) for 8 days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Intervention 1 (8 Days) |
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| Intervention 2 (8 Days) |
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| Intervention 3 (8 Days) |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | Participants received placebo, baclofen (60mg) and baclofen (90mg) and smoked Marijuana (5.3% THC). |
| 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 | Measure of Relapse: Change in Money Spent Between Baseline and Relapse Phase | This is a measure of marijuana self-administration and relapse since each initial puff costs $7 and is a burden to overcome just to smoke. Over each 3 day period, the puffs chosen by each participant is averaged for a single value. | Posted | Mean | Standard Deviation | dollars spent on marijuana | Days 1-3 (Baseline) and Days 6-8 (Relapse Phase) |
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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 | Baclofen 60, Marijuana | baclofen (60 mg)/day Baclofen: measured baclofen's effects on marijuana withdrawal and relapse relative to placebo Marijuana: measured baclofen's effects on marijuana withdrawal and relapse |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| mild headache | Social circumstances | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Margaret Haney | New York State Psychiatric Institute | 646-774-6129 | reslabsurc@gmail.com |
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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 |
|---|---|
| D001418 | Baclofen |
| C587251 | nabiximols |
| ID | Term |
|---|---|
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
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| Baclofen 90 mg, Baclofen 60 mg, Placebo | Experimental | Baclofen (60mg/day or 90 mg/day): Packaged medication in size 00 opaque capsules with riboflavin filler. Study capsules (0, 20, 30mg) were administered 3 times per day (0900, 1530, 2200). Marijuana: Participants each received a single marijuana cigarette (provided by the National Institute on Drug Abuse) at each smoking occasion. Marijuana cigarettes were stored frozen in an airtight container and humidified at room temperature for 24 h prior to use. |
|
| Placebo, Baclofen 90 mg, Baclofen 60 mg | Experimental | Baclofen (60mg/day or 90 mg/day): Packaged medication in size 00 opaque capsules with riboflavin filler. Study capsules (0, 20, 30mg) were administered 3 times per day (0900, 1530, 2200). Marijuana: Participants each received a single marijuana cigarette (provided by the National Institute on Drug Abuse) at each smoking occasion. Marijuana cigarettes were stored frozen in an airtight container and humidified at room temperature for 24 h prior to use. |
|
| Placebo, Baclofen 60 mg, Baclofen 90 mg | Experimental | Baclofen (60mg/day or 90 mg/day): Packaged medication in size 00 opaque capsules with riboflavin filler. Study capsules (0, 20, 30mg) were administered 3 times per day (0900, 1530, 2200). Marijuana: Participants each received a single marijuana cigarette (provided by the National Institute on Drug Abuse) at each smoking occasion. Marijuana cigarettes were stored frozen in an airtight container and humidified at room temperature for 24 h prior to use. |
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| Marijuana | Drug | Marijuana: Participants each received a single marijuana cigarette (provided by the National Institute on Drug Abuse) at each smoking occasion. Marijuana cigarettes were stored frozen in an airtight container and humidified at room temperature for 24 h prior to use. |
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| Placebo | Drug |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
|
| OG002 |
| Baclofen 90, Marijuana |
baclofen (90 mg)/day Baclofen: measured baclofen's effects on marijuana withdrawal and relapse relative to placebo Marijuana: measured baclofen's effects on marijuana withdrawal and relapse |
|
|
| 0 |
| 13 |
| 2 |
| 13 |
| EG001 | Baclofen 90, Marijuana | baclofen (90 mg)/day Baclofen: measured baclofen's effects on marijuana withdrawal and relapse relative to placebo Marijuana: measured baclofen's effects on marijuana withdrawal and relapse | 0 | 13 | 0 | 13 |
| EG002 | Placebo, Marijuana | Marijuana: measured baclofen's effects on marijuana withdrawal and relapse | 0 | 13 | 0 | 13 |
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| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |