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| ID | Type | Description | Link |
|---|---|---|---|
| 5P50DA009236 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Research Foundation for Mental Hygiene, Inc. | OTHER |
| National Institute on Drug Abuse (NIDA) | NIH |
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The objective of this study is to investigate the interaction between marijuana and quetiapine, with the goal of using this information to improve marijuana treatment outcome.
The purpose of this study is to determine if quetiapine decreases marijuana relapse in a controlled lab setting. 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 placebo and quetiapine (200 mg/day) for 18 days. Participants will begin taking capsules as outpatients so that the dose can be incremented prior to the inpatient phase. While inpatient, participants will have the opportunity to self-administer placebo (0.0%) or active marijuana (6.2%) 6 times per day, depending on the study day. Our laboratory model, which has distinguished the effects of a range of medications on marijuana withdrawal and relapse, will provide important information on the effect of quetiapine as a potential short-term pharmacotherapy to facilitate abstinence in the initial stages of marijuana treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Quetiapine (200mg/day), Marijuana (6.2%, 0.0%) | Experimental | Quetiapine (200mg/day): Packaged medication in size 00 opaque capsules with riboflavin filler. Study capsules (200 mg) were administered 2 times per day ((1100 and 2300 hours). 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, Marijuana (6.2%, 0.0%) | Placebo Comparator | 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 |
|---|---|---|---|---|
| Marijuana | Drug | 0,6.2% THC |
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| Measure | Description | Time Frame |
|---|---|---|
| Measure of Relapse: Change in Puffs Chosen Between Baseline and Relapse Phase | This is a measure of marijuana self-administration and relapse since each initial puff costs $10 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 |
|---|---|---|---|
| 22741619 | Result | Cooper ZD, Foltin RW, Hart CL, Vosburg SK, Comer SD, Haney M. A human laboratory study investigating the effects of quetiapine on marijuana withdrawal and relapse in daily marijuana smokers. Addict Biol. 2013 Nov;18(6):993-1002. doi: 10.1111/j.1369-1600.2012.00461.x. Epub 2012 Jun 28. |
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14 volunteers completed the study (12 males; 2 females). An additional 6 volunteers enrolled (5 males, 1 female), but did not complete.
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| ID | Title | Description |
|---|---|---|
| FG000 | Quetiapine (200mg/Day), Placebo | Quetiapine (200mg/day): Packaged medication in size 00 opaque capsules with riboflavin filler. Study capsules (200 mg) were administered 2 times per day (1100 and 2300 hours). |
| FG001 | Placebo, Quetiapine (200mg/Day) | Placebo medication (2x/day): Packaged riboflavin in size 00 opaque capsules to match size of active medication. Placebo capsules were administered 2 times per day (1100 and 2300 hours). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Intervention 1 (8 Days) |
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| Intervention 2 (8 Days) |
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Number of Baseline Participants |
| 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 Puffs Chosen Between Baseline and Relapse Phase | This is a measure of marijuana self-administration and relapse since each initial puff costs $10 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 Error | Puffs | 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 | Quetiapine (200mg/Day), Placebo | Quetiapine (200mg/day): Packaged medication in size 00 opaque capsules with riboflavin filler. Study capsules (200 mg) were administered 2 times per day (1100 and 2300 hours). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| gastrointestinal discomfort | Gastrointestinal disorders | Systematic Assessment | gastrointestinal discomfort (nausea, vomiting, stomach pain, constipation). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ziva Cooper | New York State Psychiatric Institute | 646-774-6129 | reslabsurc@gmail.com |
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| ID | Term |
|---|---|
| D008385 | Marijuana Smoking |
| D000074609 | Marijuana Use |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D000073847 | Smoking, Non-Tobacco Products |
| D012907 | Smoking |
| D019966 | Substance-Related Disorders |
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| ID | Term |
|---|---|
| C587251 | nabiximols |
| D000069348 | Quetiapine Fumarate |
| D012256 | Riboflavin |
| ID | Term |
|---|---|
| D003987 | Dibenzothiazepines |
| D013841 | Thiazepines |
| D013846 | Thiepins |
| D013457 | Sulfur Compounds |
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| Quetiapine | Drug | 200 mg/day |
|
|
| Placebo oral capsule | Drug |
|
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| NOT COMPLETED |
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| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Units | Counts |
|---|
| Participants |
|
|
| 0 |
| 20 |
| 2 |
| 20 |
| EG001 | Placebo, Quetiapine (200mg/Day) | Placebo medication (2x/day): Packaged riboflavin in size 00 opaque capsules to match size of active medication. Placebo capsules were administered 2 times per day (1100 and 2300 hours). | 0 | 20 | 1 | 20 |
|
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| D001523 |
| Mental Disorders |
| D009930 |
| Organic Chemicals |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005415 | Flavins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D010860 | Pigments, Biological |
| D001685 | Biological Factors |