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Effects of a Range of Naltrexone Doses in Combination With Smoked Marijuana

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00403117
Recruitment Status : Completed
First Posted : November 23, 2006
Results First Posted : December 19, 2017
Last Update Posted : March 15, 2018
Sponsor:
Collaborators:
Research Foundation for Mental Hygiene, Inc.
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
New York State Psychiatric Institute

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Marijuana Use Drug: Placebo + Inactive Marijuana (0% THC) Drug: Placebo + Active Marijuana (3.27% THC) Drug: Naltrexone 12 Mg+ Active Marijuana (3.27% THC) Drug: Naltrexone 25 Mg + Active Marijuana (3.27% THC) Drug: Naltrexone 50 Mg+ Active Marijuana (3.27% THC) Drug: Naltrexone 100 Mg+ Active Marijuana (3.27% THC) Drug: Naltrexone 12 Mg + Inactive Marijuana (0% THC) Drug: Naltrexone 25 Mg + Inactive Marijuana (0% THC) Drug: Naltrexone 50 Mg + Inactive Marijuana (0% THC) Drug: Naltrexone 100 Mg + Inactive Marijuana (0% THC) Phase 2

Detailed Description:
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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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Masking Description: double-blind, placebo-controlled
Primary Purpose: Basic Science
Official Title: Opioid Antagonism Enhances Marijuana's Effects in Heavy Marijuana Smokers
Study Start Date : December 2006
Actual Primary Completion Date : May 2008
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana

Arm Intervention/treatment
Placebo Comparator: Placebo, Marijuana (0% THC)
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.
Drug: Placebo + Inactive Marijuana (0% THC)
One capsule containing placebo was administered to the participant in a size 00 opaque capsules with lactose filler 45 minutes before marijuana administration.
Other Name: treatment type 1

Experimental: Placebo, Marijuana (3.27% THC)
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.
Drug: Placebo + Active Marijuana (3.27% THC)
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.
Other Name: treatment type 2

Experimental: Naltrexone (12mg), Marijuana (0% THC)
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.
Drug: Naltrexone 12 Mg + Inactive Marijuana (0% THC)
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.
Other Name: treatment type 7

Experimental: Naltrexone (12mg), Marijuana (3.27% THC)
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.
Drug: Naltrexone 12 Mg+ Active Marijuana (3.27% THC)
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.
Other Name: Treatment type 3

Experimental: Naltrexone (25mg), Marijuana (0% THC)
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.
Drug: Naltrexone 25 Mg + Inactive Marijuana (0% THC)
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.
Other Name: treatment type 8

Experimental: Naltrexone (25mg), Marijuana (3.27% THC)
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.
Drug: Naltrexone 25 Mg + Active Marijuana (3.27% THC)
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.
Other Name: treatment type 4

Experimental: Naltrexone (50mg), Marijuana (0% THC)
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.
Drug: Naltrexone 50 Mg + Inactive Marijuana (0% THC)
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.
Other Name: treatment type 9

Experimental: Naltrexone (50mg), Marijuana (3.27% THC)
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.
Drug: Naltrexone 50 Mg+ Active Marijuana (3.27% THC)
One capsule containing 25mg Naltrexone was administered to the participant in a size 00 opaque capsules with lactose filler 45 minutes before marijuana administration.
Other Name: treatment type 5

Experimental: Naltrexone (100mg), Marijuana (0% THC)
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.
Drug: Naltrexone 100 Mg + Inactive Marijuana (0% THC)
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.
Other Name: treatment type 10

Experimental: Naltrexone (100mg), Marijuana (3.27% THC)
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.
Drug: Naltrexone 100 Mg+ Active Marijuana (3.27% THC)
One capsule containing 50mg Naltrexone was administered to the participant in a size 00 opaque capsules with lactose filler 45 minutes before marijuana administration.
Other Name: treatment type 6




Primary Outcome Measures :
  1. Change in Mean Subjective Mood Scores as a Function of Marijuana Strength and Naltrexone Dose. [ Time Frame: Baseline compared to 6 week timepoint ]

    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)


  2. Change in Mean Psychomotor Task Performance as a Function of Marijuana Strength and Naltrexone Dose [ Time Frame: Baseline compared to 6 week timepoint ]

    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.


  3. Change in Mean Heart Rate as a Function of Marijuana Strength and Naltrexone Dose. [ Time Frame: Baseline compared to 6 week timepoint ]
    Change in mean heart rate as a function of marijuana and naltrexone dose



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Current marijuana use
  • Able to perform study procedures
  • 21-45 years of age
  • Women practicing an effective form of birth control

Exclusion Criteria:

  • Current, repeated illicit drug use (other than marijuana)
  • Presence of significant medical illness (e.g., diabetes, cardiovascular disease, hypertension, examination, laboratory hepatitis, clinically significant laboratory abnormalities, tests, 12-lead ECG, Mantoux test LFTs > 3x upper limit of normal)
  • History of heart disease
  • Request for drug treatment
  • Current parole or probation
  • Pregnancy or current lactation
  • Recent history of significant violent behavior
  • Previous adverse reaction to naltrexone
  • Major current Axis I psychopathology Psychiatric interview (e.g., major depressive disorder, bipolar disorder, suicide risk, schizophrenia)
  • Current use of any prescription or over-the-counter medication

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00403117


Sponsors and Collaborators
New York State Psychiatric Institute
Research Foundation for Mental Hygiene, Inc.
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Margaret Haney, Ph.D. New York State Psychiatric Institute
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Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00403117    
Other Study ID Numbers: IRB# 5350
DA09236 ( Other Grant/Funding Number: National Institute on Drug Abuse (NIDA) )
First Posted: November 23, 2006    Key Record Dates
Results First Posted: December 19, 2017
Last Update Posted: March 15, 2018
Last Verified: February 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by New York State Psychiatric Institute:
Naltrexone
Smoked Marijuana
Additional relevant MeSH terms:
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Marijuana Abuse
Marijuana Use
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Naltrexone
Alcohol Deterrents
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents