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| ID | Type | Description | Link |
|---|---|---|---|
| DA09236 | 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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The purpose of this study is to determine if the subjective effects of marijuana will be decreased by low-doses (< 25 mg) of naltrexone and increased by high-doses (> 50 mg) of naltrexone.
Laboratory animal studies demonstrate that endogenous cannabinoids and opioids are closely inter-related. We have completed a series of studies in marijuana smokers showing that a clinically-utilized dose of naltrexone (50 mg) enhanced the reinforcing and subjective effects of orally-administered tetrahydrocannabinol (THC), while a low naltrexone dose (12 mg) blunted the effects of THC. A better understanding of the effects of a range of naltrexone doses in combination with smoked marijuana has important implications for the following reasons: (1) Alcohol- and opioid-dependent patients receive high doses of naltrexone (50-150 mg), which may increase the abuse liability of marijuana, (2) Low-dose naltrexone blunts THC's intoxicating effects, suggesting potential utility as a treatment medication for marijuana dependence. This study will determine if naltrexone (0, 12, 25, 50, 100 mg) administration 45 min prior to marijuana administration (0, 3.27% THC) alters marijuana's subjective, cognitive or physiological effects. Marijuana smokers will spend approximately 5h/day for a total of 10 days in the outpatient laboratory. Participants will visit the outpatient laboratory 2-3 times per week, with a minimum 48-hr interval between sessions to allow for naltrexone clearance. These data will provide important information regarding the clinical use of naltrexone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo, Marijuana (0% THC) | Placebo Comparator | During each session, one capsule containing placebo was administered to the participant in a size 00 opaque capsule with lactose filler. A marijuana cigarette (0% THC; ca. 800 mg) provided by the National Institute on Drug Abuse, was administered 45 minutes post capsule administration. |
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| Placebo, Marijuana (3.27% THC) | Experimental | During each session, one capsule containing placebo was administered to the participant in a size 00 opaque capsule with lactose filler. A marijuana cigarette (3.27% THC; ca. 800 mg) provided by the National Institute on Drug Abuse, was administered 45 minutes post capsule administration. |
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| Naltrexone (12mg), Marijuana (0% THC) | Experimental | During each session, one capsule containing naltrexone (12 mg) was administered to the participant in a size 00 opaque capsule with lactose filler. A marijuana cigarette (0% THC; ca. 800 mg) provided by the National Institute on Drug Abuse, was administered 45 minutes post capsule administration. |
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| Naltrexone (12mg), Marijuana (3.27% THC) | Experimental | During each session, one capsule containing naltrexone (12 mg) was administered to the participant in a size 00 opaque capsule with lactose filler. A marijuana cigarette (3.27% THC; ca. 800 mg) provided by the National Institute on Drug Abuse, was administered 45 minutes post capsule administration. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo + Inactive Marijuana (0% THC) | Drug | One capsule containing placebo was administered to the participant in a size 00 opaque capsules with lactose filler 45 minutes before marijuana administration. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Mean Subjective Mood Scores as a Function of Marijuana Strength and Naltrexone Dose. | All subjective effects were measured using visual analog scales (VAS), 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 rate their subjective experiences on the line according to how they felt at that particular moment. Subjective assessments included measures of perceived marijuana strength, marijuana "high", "good effects" of marijuana, and how much marijuana was "liked". Marijuana's effects were determined by comparing the active and inactive marijuana conditions when paired with the placebo naltrexone condition (one comparison). Naltrexone's intrinsic effects were assessed by comparing placebo and each active dose of naltrexone (12, 25, 50, and 100 mg) under the inactive marijuana condition (four comparisons). Finally, the active marijuana- placebo naltrexone condition was compared to the active marijuana-active naltrexone conditions (four comparisons) | Baseline compared to 6 week timepoint |
| Change in Mean Psychomotor Task Performance as a Function of Marijuana Strength and Naltrexone Dose | Change in Digit Symbol Substitution Test (DSST) scores. Increasing scores indicate improvement, on a scale of 0-90. The task batteries included total correct attempts on a 3-min DSST. | Baseline compared to 6 week timepoint |
| Change in Mean Heart Rate as a Function of Marijuana Strength and Naltrexone Dose. | Change in mean heart rate as a function of marijuana and naltrexone dose | Baseline compared to 6 week timepoint |
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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 |
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A total of 15 males and 14 females completed this study, which used a within-subject design such that each participant received 10 different drug treatments/interventions in total.
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| ID | Title | Description |
|---|---|---|
| FG000 | Overall Study Participant Flow | Of the 49 participants enrolled, only 29 completed all 10 drug interventions. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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double-blind, placebo-controlled
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| Naltrexone (25mg), Marijuana (0% THC) | Experimental | During each session, one capsule containing naltrexone (25 mg) was administered to the participant in a size 00 opaque capsule with lactose filler. A marijuana cigarette (0% THC; ca. 800 mg) provided by the National Institute on Drug Abuse, was administered 45 minutes post capsule administration. |
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| Naltrexone (25mg), Marijuana (3.27% THC) | Experimental | During each session, one capsule containing naltrexone (25 mg) was administered to the participant in a size 00 opaque capsule with lactose filler. A marijuana cigarette (3.27% THC; ca. 800 mg) provided by the National Institute on Drug Abuse, was administered 45 minutes post capsule administration. |
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| Naltrexone (50mg), Marijuana (0% THC) | Experimental | During each session, one capsule containing naltrexone (50 mg) was administered to the participant in a size 00 opaque capsule with lactose filler. A marijuana cigarette (0% THC; ca. 800 mg) provided by the National Institute on Drug Abuse, was administered 45 minutes post capsule administration. |
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| Naltrexone (50mg), Marijuana (3.27% THC) | Experimental | During each session, one capsule containing naltrexone (50 mg) was administered to the participant in a size 00 opaque capsule with lactose filler. A marijuana cigarette (3.27% THC; ca. 800 mg) provided by the National Institute on Drug Abuse, was administered 45 minutes post capsule administration. |
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| Naltrexone (100mg), Marijuana (0% THC) | Experimental | During each session, one capsule containing naltrexone (100 mg) was administered to the participant in a size 00 opaque capsule with lactose filler. A marijuana cigarette (0% THC; ca. 800 mg) provided by the National Institute on Drug Abuse, was administered 45 minutes post capsule administration. |
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| Naltrexone (100mg), Marijuana (3.27% THC) | Experimental | During each session, one capsule containing naltrexone (100 mg) was administered to the participant in a size 00 opaque capsule with lactose filler. A marijuana cigarette (3.27% THC; ca. 800 mg) provided by the National Institute on Drug Abuse, was administered 45 minutes post capsule administration. |
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| Placebo + Active Marijuana (3.27% THC) | Drug | One capsule containing placebo was administered to the participant in a size 00 opaque capsules with lactose filler 45 minutes before administration of a marijuana cigarette containing 3.27% THC (ca. 800 mg) provided by the National Institute on Drug Abuse. |
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| Naltrexone 12 Mg+ Active Marijuana (3.27% THC) | Drug | One capsule containing 12mg Naltrexone was administered to the participant in a size 00 opaque capsules with lactose filler 45 minutes before active marijuana administration. |
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| Naltrexone 25 Mg + Active Marijuana (3.27% THC) | Drug | One capsule containing 12mg Naltrexone was administered to the participant in a size 00 opaque capsules with lactose filler 45 minutes before active marijuana administration. |
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| Naltrexone 50 Mg+ Active Marijuana (3.27% THC) | Drug | One capsule containing 25mg Naltrexone was administered to the participant in a size 00 opaque capsules with lactose filler 45 minutes before marijuana administration. |
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| Naltrexone 100 Mg+ Active Marijuana (3.27% THC) | Drug | One capsule containing 50mg Naltrexone was administered to the participant in a size 00 opaque capsules with lactose filler 45 minutes before marijuana administration. |
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| Naltrexone 12 Mg + Inactive Marijuana (0% THC) | Drug | One capsule containing 12mg Naltrexone was administered to the participant in a size 00 opaque capsules with lactose filler 45 minutes before inactive marijuana administration. |
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| Naltrexone 25 Mg + Inactive Marijuana (0% THC) | Drug | One capsule containing 25mg Naltrexone was administered to the participant in a size 00 opaque capsules with lactose filler 45 minutes before inactive marijuana administration. |
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| Naltrexone 50 Mg + Inactive Marijuana (0% THC) | Drug | One capsule containing 50mg Naltrexone was administered to the participant in a size 00 opaque capsules with lactose filler 45 minutes before inactive marijuana administration. |
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| Naltrexone 100 Mg + Inactive Marijuana (0% THC) | Drug | One capsule containing 100mg Naltrexone was administered to the participant in a size 00 opaque capsules with lactose filler 45 minutes before inactive marijuana administration. |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Number of Baseline Participants | Baseline measures are only reported for the 29 participants who completed the study. |
| 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 | Participants |
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| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| 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 | |||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Change in Mean Subjective Mood Scores as a Function of Marijuana Strength and Naltrexone Dose. | All subjective effects were measured using visual analog scales (VAS), 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 rate their subjective experiences on the line according to how they felt at that particular moment. Subjective assessments included measures of perceived marijuana strength, marijuana "high", "good effects" of marijuana, and how much marijuana was "liked". Marijuana's effects were determined by comparing the active and inactive marijuana conditions when paired with the placebo naltrexone condition (one comparison). Naltrexone's intrinsic effects were assessed by comparing placebo and each active dose of naltrexone (12, 25, 50, and 100 mg) under the inactive marijuana condition (four comparisons). Finally, the active marijuana- placebo naltrexone condition was compared to the active marijuana-active naltrexone conditions (four comparisons) | Data from 29 participants were included in this analysis. | Posted | Mean | Standard Deviation | units on a scale | Baseline compared to 6 week timepoint |
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| Primary | Change in Mean Psychomotor Task Performance as a Function of Marijuana Strength and Naltrexone Dose | Change in Digit Symbol Substitution Test (DSST) scores. Increasing scores indicate improvement, on a scale of 0-90. The task batteries included total correct attempts on a 3-min DSST. | Data from 29 participants were included in this analysis | Posted | Mean | Standard Error | units on a scale | Baseline compared to 6 week timepoint |
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| Primary | Change in Mean Heart Rate as a Function of Marijuana Strength and Naltrexone Dose. | Change in mean heart rate as a function of marijuana and naltrexone dose | A total of 29 participants were included in the final analysis | Posted | Mean | Standard Deviation | Heart rate (beats/minute) | Baseline compared to 6 week timepoint |
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Adverse events were collected for the six weeks that each participant was enrolled in the study.
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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 + Inactive Marijuana (0.0%THC) | In this arm, participants received placebo + inactive marijuana (0.0%THC) | 0 | 49 | 0 | 49 | 0 | 49 |
| EG001 | Placebo + Marijuana (3.27% THC) | In this arm, participants received placebo + Marijuana (3.27% THC) | 0 | 49 | 0 | 49 | 0 | 49 |
| EG002 | Naltrexone (12mg) + Marijuana (0.0%THC) | In this arm, participants received naltrexone (12mg) + marijuana (0.0%THC) | 0 | 49 | 0 | 49 | 0 | 49 |
| EG003 | Naltrexone (12mg) + Marijuana (3.27%THC) | In this arm, participants received naltrexone (12mg) + marijuana (3.27%THC) | 0 | 49 | 0 | 49 | 7 | 49 |
| EG004 | Naltrexone (25mg) + Marijuana (0.0%THC) | In this arm, participants received naltrexone (25mg) + marijuana (0.0%THC) | 0 | 49 | 0 | 49 | 12 | 49 |
| EG005 | Naltrexone (25mg) + Marijuana (3.27%THC) | In this arm, participants received naltrexone (25mg) + marijuana (3.27%THC) | 0 | 49 | 0 | 49 | 1 | 49 |
| EG006 | Naltrexone (50mg) + Marijuana (0.0%THC) | In this arm, participants received naltrexone (50mg) + marijuana (0.0%THC) | 0 | 49 | 0 | 49 | 0 | 49 |
| EG007 | Naltrexone (50mg) + Marijuana (3.27%THC) | In this arm, participants received naltrexone (50mg) + marijuana (3.27%THC) | 0 | 49 | 0 | 49 | 0 | 49 |
| EG008 | Naltrexone (100mg) + Marijuana (0.0%THC) | In this arm, participants received naltrexone (100mg) + marijuana (0.0%THC) | 0 | 49 | 0 | 49 | 0 | 49 |
| EG009 | Naltrexone (100mg) + Marijuana (3.27%THC) | In this arm, participants received naltrexone (100mg) + marijuana (3.27%THC) | 0 | 49 | 0 | 49 | 0 | 49 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| gastrointestinal upset | Gastrointestinal disorders | Systematic Assessment |
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| conflicting social circumstance | Social circumstances | Systematic Assessment |
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A limitation of this study is the small sample size.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Margaret Haney, PhD | New York State Psychiatric Institute | 646-774-6153 | mh235@cumc.columbia.edu |
| ID | Term |
|---|---|
| D000074609 | Marijuana Use |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D019966 | Substance-Related Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D013759 | Dronabinol |
| D009271 | Naltrexone |
| ID | Term |
|---|---|
| D002186 | Cannabinoids |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| 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 |
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| Naltrexone (100mg) + Marijuana (3.27%THC) |
naltrexone + active marijuana |
| Mean VAS ratings "High" |
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| Mean VAS ratings "Good Effect" |
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| Mean VAS ratings "Like Drug" |
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Placebo marijuana (3.27% THC)
Naltrexone: During each session, one capsule containing placebo or naltrexone (12, 25, 50, and 100 mg) was administered to the participant in a size 00 opaque capsules with lactose filler, prepared by the New York State Psychiatric Institute Research Pharmacy. A marijuana cigarette (0 or 3.27% THC; ca. 800 mg) provided by the National Institute on Drug Abuse was smoked 45 min after naltrexone administration, the time at which naltrexone levels peak.
Marijuana: During each session, one capsule containing placebo or naltrexone (12, 25, 50, and 100 mg) was administered to the participant in a size 00 opaque capsules with lactose filler, prepared by the New York State Psychiatric Institute Research Pharmacy. A marijuana cigarette (0 or 3.27% THC; ca. 800 mg) provided by the National Institute on Drug Abuse was smoked 45 min after naltrexone administration, the time at which naltrexone levels peak.
| OG002 | Naltrexone (12mg) + Marijuana (0.0%THC) | Naltrexone + Inactive marijuana |
| OG003 | Naltrexone (12mg) + Marijuana (3.27%THC) | naltrexone + active marijuana |
| OG004 | Naltrexone (25mg) + Marijuana (0.0%THC) | Naltrexone + Inactive marijuana |
| OG005 | Naltrexone (25mg) + Marijuana (3.27%THC) | naltrexone + active marijuana |
| OG006 | Naltrexone (50mg) + Marijuana (0.0%THC) | Naltrexone + Inactive marijuana |
| OG007 | Naltrexone (50mg) + Marijuana (3.27%THC) | naltrexone + active marijuana |
| OG008 | Naltrexone (100mg) + Marijuana (0.0%THC) | Naltrexone + Inactive marijuana |
| OG009 | Naltrexone (100mg) + Marijuana (3.27%THC) | naltrexone + active marijuana |
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| OG002 | Naltrexone (12mg) + Marijuana (0.0%THC) | Naltrexone + Inactive marijuana |
| OG003 | Naltrexone (12mg) + Marijuana (3.27%THC) | naltrexone + active marijuana |
| OG004 | Naltrexone (25mg) + Marijuana (0.0%THC) | Naltrexone + Inactive marijuana |
| OG005 | Naltrexone (25mg) + Marijuana (3.27%THC) | naltrexone + active marijuana |
| OG006 | Naltrexone (50mg) + Marijuana (0.0%THC) | Naltrexone + Inactive marijuana |
| OG007 | Naltrexone (50mg) + Marijuana (3.27%THC) | naltrexone + active marijuana |
| OG008 | Naltrexone (100mg) + Marijuana (0.0%THC) | Naltrexone + Inactive marijuana |
| OG009 | Naltrexone (100mg) + Marijuana (3.27%THC) | naltrexone + active marijuana |
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