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| ID | Type | Description | Link |
|---|---|---|---|
| DA19239 | Other Grant/Funding Number | National Institute on Drug Abuse (NIDA) |
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| Name | Class |
|---|---|
| Research Foundation for Mental Hygiene, Inc. | OTHER |
| National Institute on Drug Abuse (NIDA) | NIH |
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In heavy marijuana smokers, opioid receptor blockade increases the subjective and cardiovascular effects of marijuana. The current study was designed to clarify opioid-cannabinoid interactions by assessing how naltrexone shifts the dose-response function for marijuana-elicited effects in heavy marijuana smokers. For this within-subject, double-blind study, a marijuana smoking procedure was designed to characterize a dose-response relationship for marijuana's subjective and cardiovascular effects under blinded conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo naltrexone + Inactive marijuana | Placebo Comparator | Placebo naltrexone capsules (0mg), inactive marijuana (0% THC). Each study participant underwent 8 conditions in a randomized order. |
|
| Placebo naltrexone + Active marijuana (5.5% THC) | Placebo Comparator | Placebo naltrexone capsules (0mg), active marijuana (5.5% THC). Each study participant underwent 8 conditions in a randomized order. |
|
| Placebo naltrexone + Active marijuana (6.2% THC) | Placebo Comparator | Placebo naltrexone capsules (0mg), active marijuana (6.2% THC). Each study participant underwent 8 conditions in a randomized order. |
|
| Naltrexone + Active marijuana (5.5% THC) | Experimental | Naltrexone capsules (12mg), active marijuana (5.5% THC). Each study participant underwent 8 conditions in a randomized order. |
|
| Naltrexone + Active marijuana (6.2% THC) | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inactive Marijuana (0% THC) | Drug | Marijuana cigarette containing 0% THC |
|
| Measure | Description | Time Frame |
|---|---|---|
| Subjective Marijuana Effects | Subjective ratings of marijuana's quality and effect ('Strength', 'Good Effect', 'High', 'Stimulation') and craving ('Want Marijuana') as a function of active puffs and naltrexone, using a visual analogue scale with a series of 100 mm long lines labeled 'not at all' at one end (0 mm) and 'extremely' at the other end (100 mm). Participants were instructed to indicate how they felt at that particular moment. Higher ratings indicate more agreement with the statement. | 180 minutes after marijuana administration, during each of 8 outpatient sessions over the course of 3-6 weeks. |
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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 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo, Naltrexone, Marijuana | A total of 23 participants enrolled but only 19 completed. All patients participated in all conditions; they were randomized to placebo or naltrexone treatment in a counterbalanced fashion, and underwent all smoking conditions in separate, counterbalanced sessions. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
19 participants completed the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo, Naltrexone, Marijuana | During each of the 8 outpatient sessions, participants smoked a total of 6 puffs from 3 marijuana cigarettes (2 puffs from each cigarette). Marijuana administration occurred 45 minutes after capsule administration. The number of active versus inactive cigarettes smoked during each session varied, according to active puff conditions (i.e., 0 puffs = 3 inactive cigarettes; 2 puffs = 1 active + 2 inactive cigarette; 4 puffs = 2 active + 1 inactive cigarette; 6 puffs = 3 active + 0 inactive cigarette). Cigarettes were color coded, indicating the order in which they were to be smoked and active cigarettes were always smoked before inactive. A within-subject design was used in which all participants were exposed to each of the puff conditions in combination with naltrexone or placebo. The order of naltrexone dosing and puff condition was randomized within the session and across participants. |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Subjective Marijuana Effects | Subjective ratings of marijuana's quality and effect ('Strength', 'Good Effect', 'High', 'Stimulation') and craving ('Want Marijuana') as a function of active puffs and naltrexone, using a visual analogue scale with a series of 100 mm long lines labeled 'not at all' at one end (0 mm) and 'extremely' at the other end (100 mm). Participants were instructed to indicate how they felt at that particular moment. Higher ratings indicate more agreement with the statement. | Posted | Mean | Standard Error | units on a scale (0-100mm) | 180 minutes after marijuana administration, during each of 8 outpatient sessions over the course of 3-6 weeks. |
|
4 weeks for each treatment and 1 week after receiving last treatment.
Safety population included all participants who received at least one intervention. Research staff routinely asked participants to report any adverse events occurring during study sessions and during outpatient washout periods.
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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 Naltrexone + Inactive Marijuana (0.0% THC) | 0mg naltrexone + 0.0% THC marijuana |
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This study is limited by its small sample size, and portion of males to females.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Margaret Haney, PhD | New York State Psychiatric Institute | 646-774-6153 | mh235@cumc.columbia.edu |
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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 |
|---|---|
| D013759 | Dronabinol |
| C587251 | nabiximols |
| D009271 | Naltrexone |
| ID | Term |
|---|---|
| D002186 | Cannabinoids |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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Double-blind, placebo-controlled
Naltrexone capsules (0mg), active marijuana (6.2% THC). Each study participant underwent 8 conditions in a randomized order.
|
| Naltrexone + Inactive marijuana | Placebo Comparator | Naltrexone capsules (12mg), inactive marijuana (0% THC). Each study participant underwent 8 conditions in a randomized order. |
|
| Active Marijuana (5.5% THC) | Drug | Marijuana cigarette containing 5.5% THC |
|
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| Active Marijuana (6.2% THC) | Drug | Marijuana cigarette containing 6.2% THC |
|
|
| Naltrexone | Drug | Naltrexone (12mg/70kg) |
|
|
| Placebo naltrexone | Drug | Naltrexone (0mg) |
|
|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | Placebo Naltrexone + Active Marijuana (5.5% THC) | Placebo naltrexone capsules (0mg), active marijuana (5.5% THC). Each study participant underwent 8 conditions in a randomized order. Active Marijuana (5.5% THC): Marijuana cigarette containing 5.5% THC Placebo naltrexone: Naltrexone (0mg) |
| OG002 | Placebo Naltrexone + Active Marijuana (6.2% THC) | Placebo naltrexone capsules (0mg), active marijuana (6.2% THC). Each study participant underwent 8 conditions in a randomized order. Active Marijuana (6.2% THC): Marijuana cigarette containing 6.2% THC Placebo naltrexone: Naltrexone (0mg) |
| OG003 | Naltrexone + Active Marijuana (5.5% THC) | Naltrexone capsules (12mg), active marijuana (5.5% THC). Each study participant underwent 8 conditions in a randomized order. Active Marijuana (5.5% THC): Marijuana cigarette containing 5.5% THC Naltrexone: Naltrexone (12mg/70kg) |
| OG004 | Naltrexone + Active Marijuana (6.2% THC) | Naltrexone capsules (0mg), active marijuana (6.2% THC). Each study participant underwent 8 conditions in a randomized order. Active Marijuana (6.2% THC): Marijuana cigarette containing 6.2% THC Naltrexone: Naltrexone (12mg/70kg) |
| OG005 | Naltrexone + Inactive Marijuana | Naltrexone capsules (12mg), inactive marijuana (0% THC). Each study participant underwent 8 conditions in a randomized order. Inactive Marijuana (0% THC): Marijuana cigarette containing 0% THC Naltrexone: Naltrexone (12mg/70kg) |
|
|
| 0 |
| 23 |
| 0 |
| 23 |
| 0 |
| 23 |
| EG001 | Placebo Naltrexone + Active Marijuana (5.5% THC) | 0mg naltrexone + 5.5% THC marijuana | 0 | 23 | 0 | 23 | 0 | 23 |
| EG002 | Placebo Naltrexone + Active Marijuana (6.2% THC) | 0mg naltrexone + 6.2% THC marijuana | 0 | 23 | 0 | 23 | 0 | 23 |
| EG003 | Naltrexone + Inactive Marijuana (0.0% THC) | 12mg naltrexone + 0.0% THC marijuana | 0 | 23 | 0 | 23 | 0 | 23 |
| EG004 | Naltrexone + Active Marijuana (5.5% THC) | 12mg naltrexone + 5.5% THC marijuana | 0 | 23 | 0 | 23 | 0 | 23 |
| EG005 | Naltrexone + Active Marijuana (6.2% THC) | 12mg naltrexone + 6.2% THC marijuana | 0 | 23 | 0 | 23 | 0 | 23 |
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| D001523 |
| Mental Disorders |
| D009270 |
| Naloxone |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |