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

NCT00403117 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: IRB# 5350DA09236
• Study Type: interventional
• Target: 49
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Marijuana Use

Keywords

Naltrexone; Smoked Marijuana

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (10)

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.

Drug: Placebo + Inactive Marijuana (0% THC)

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.

Drug: Placebo + Active Marijuana (3.27% THC)

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.

Drug: Naltrexone 12 Mg + Inactive Marijuana (0% THC)

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.

Drug: Naltrexone 12 Mg+ Active Marijuana (3.27% THC)

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.

Drug: Naltrexone 25 Mg + Inactive Marijuana (0% THC)

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.

Drug: Naltrexone 25 Mg + Active Marijuana (3.27% THC)

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.

Drug: Naltrexone 50 Mg + Inactive Marijuana (0% THC)

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.

Drug: Naltrexone 50 Mg+ Active Marijuana (3.27% THC)

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.

Drug: Naltrexone 100 Mg + Inactive Marijuana (0% THC)

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.

Drug: Naltrexone 100 Mg+ Active Marijuana (3.27% THC)

Interventions

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.

Also known as: treatment type 1

Placebo, Marijuana (0% THC)

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.

Also known as: treatment type 2

Placebo, Marijuana (3.27% THC)

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.

Also known as: Treatment type 3

Naltrexone (12mg), Marijuana (3.27% THC)

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.

Also known as: treatment type 4

Naltrexone (25mg), Marijuana (3.27% THC)

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.

Also known as: treatment type 5

Naltrexone (50mg), Marijuana (3.27% THC)

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.

Also known as: treatment type 6

Naltrexone (100mg), Marijuana (3.27% THC)

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.

Also known as: treatment type 7

Naltrexone (12mg), Marijuana (0% THC)

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.

Also known as: treatment type 8

Naltrexone (25mg), Marijuana (0% THC)

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.

Also known as: treatment type 9

Naltrexone (50mg), Marijuana (0% THC)

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.

Also known as: treatment type 10

Naltrexone (100mg), Marijuana (0% THC)

Eligibility Criteria

• Age: 21 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• New York State Psychiatric Institute: lead
• Research Foundation for Mental Hygiene, Inc.: collaborator
• National Institute on Drug Abuse (NIDA): collaborator

MeSH Terms

Conditions

Marijuana Use

Interventions

Dronabinol; Naltrexone

Condition Hierarchy (Ancestors)

Behavior; Substance-Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals; Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Limitations and Caveats

A limitation of this study is the small sample size.

Results Point of Contact

• Title: Margaret Haney, PhD
• Organization: New York State Psychiatric Institute

mh235@cumc.columbia.edu

646-774-6153

Study Officials

• Margaret Haney, Ph.D.

  New York State Psychiatric Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: double-blind, placebo-controlled
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2006
• First Posted: November 23, 2006
• Study Start: December 1, 2006
• Primary Completion: May 1, 2008
• Study Completion: August 1, 2010
• Last Updated: March 15, 2018
• Results First Posted: December 19, 2017

Record last verified: 2018-02