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

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

Interventions

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Sponsors & Collaborators

• Research Foundation for Mental Hygiene, Inc.

  collaborator OTHER

• National Institute on Drug Abuse (NIDA)

  collaborator NIH

• New York State Psychiatric Institute

  lead OTHER

Principal Investigators

• Margaret Haney, Ph.D. · New York State Psychiatric Institute

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Model

SINGLE_GROUP

Eligibility

Min Age

21 Years

Max Age

45 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2006-12-31

Primary Completion

2008-05-31

Completion

2010-08-31

FDA Drug

Yes