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

NCT ID: NCT00403117

Last Updated: 2018-03-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-12-31
• Study Completion Date: 2010-08-31

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.

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.

Conditions

Marijuana Use

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: PLACEBO_COMPARATOR

Placebo + Inactive Marijuana (0% THC)

Intervention Type: DRUG

One capsule containing placebo was administered to the participant in a size 00 opaque capsules with lactose filler 45 minutes before marijuana administration.

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.

Group Type: EXPERIMENTAL

Placebo + Active Marijuana (3.27% THC)

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

Naltrexone 12 Mg + Inactive Marijuana (0% THC)

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

Naltrexone 12 Mg+ Active Marijuana (3.27% THC)

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

Naltrexone 25 Mg + Inactive Marijuana (0% THC)

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

Naltrexone 25 Mg + Active Marijuana (3.27% THC)

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

Naltrexone 50 Mg + Inactive Marijuana (0% THC)

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

Naltrexone 50 Mg+ Active Marijuana (3.27% THC)

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

Naltrexone 100 Mg + Inactive Marijuana (0% THC)

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

Naltrexone 100 Mg+ Active Marijuana (3.27% THC)

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

treatment type 1; treatment type 2; Treatment type 3; treatment type 4; treatment type 5; treatment type 6; treatment type 7; treatment type 8; treatment type 9; treatment type 10

Eligibility 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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Research Foundation for Mental Hygiene, Inc.

OTHER

Sponsor Role: collaborator

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

New York State Psychiatric Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Margaret Haney, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

New York State Psychiatric Institute

Other Identifiers

DA09236

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IRB# 5350

Identifier Type: -

Identifier Source: org_study_id