Effects of Low-dose Naltrexone in Combination With a Range of Smoked Marijuana

NCT ID: NCT00743145

Last Updated: 2018-09-14

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2009-09-30

Brief Summary

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In heavy marijuana smokers, opioid receptor blockade increases the subjective and cardiovascular effects of marijuana. The current study was designed to clarify opioid-cannabinoid interactions by assessing how naltrexone shifts the dose-response function for marijuana-elicited effects in heavy marijuana smokers. For this within-subject, double-blind study, a marijuana smoking procedure was designed to characterize a dose-response relationship for marijuana's subjective and cardiovascular effects under blinded conditions.

Detailed Description

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Conditions

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Marijuana Smoking

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators
Double-blind, placebo-controlled

Study Groups

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Placebo naltrexone + Inactive marijuana

Placebo naltrexone capsules (0mg), inactive marijuana (0% THC). Each study participant underwent 8 conditions in a randomized order.

Group Type PLACEBO_COMPARATOR

Inactive Marijuana (0% THC)

Intervention Type DRUG

Marijuana cigarette containing 0% THC

Placebo naltrexone

Intervention Type DRUG

Naltrexone (0mg)

Placebo naltrexone + Active marijuana (5.5% THC)

Placebo naltrexone capsules (0mg), active marijuana (5.5% THC). Each study participant underwent 8 conditions in a randomized order.

Group Type PLACEBO_COMPARATOR

Active Marijuana (5.5% THC)

Intervention Type DRUG

Marijuana cigarette containing 5.5% THC

Placebo naltrexone

Intervention Type DRUG

Naltrexone (0mg)

Placebo naltrexone + Active marijuana (6.2% THC)

Placebo naltrexone capsules (0mg), active marijuana (6.2% THC). Each study participant underwent 8 conditions in a randomized order.

Group Type PLACEBO_COMPARATOR

Active Marijuana (6.2% THC)

Intervention Type DRUG

Marijuana cigarette containing 6.2% THC

Placebo naltrexone

Intervention Type DRUG

Naltrexone (0mg)

Naltrexone + Active marijuana (5.5% THC)

Naltrexone capsules (12mg), active marijuana (5.5% THC). Each study participant underwent 8 conditions in a randomized order.

Group Type EXPERIMENTAL

Active Marijuana (5.5% THC)

Intervention Type DRUG

Marijuana cigarette containing 5.5% THC

Naltrexone

Intervention Type DRUG

Naltrexone (12mg/70kg)

Naltrexone + Active marijuana (6.2% THC)

Naltrexone capsules (0mg), active marijuana (6.2% THC). Each study participant underwent 8 conditions in a randomized order.

Group Type EXPERIMENTAL

Active Marijuana (6.2% THC)

Intervention Type DRUG

Marijuana cigarette containing 6.2% THC

Naltrexone

Intervention Type DRUG

Naltrexone (12mg/70kg)

Naltrexone + Inactive marijuana

Naltrexone capsules (12mg), inactive marijuana (0% THC). Each study participant underwent 8 conditions in a randomized order.

Group Type PLACEBO_COMPARATOR

Inactive Marijuana (0% THC)

Intervention Type DRUG

Marijuana cigarette containing 0% THC

Naltrexone

Intervention Type DRUG

Naltrexone (12mg/70kg)

Interventions

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Inactive Marijuana (0% THC)

Marijuana cigarette containing 0% THC

Intervention Type DRUG

Active Marijuana (5.5% THC)

Marijuana cigarette containing 5.5% THC

Intervention Type DRUG

Active Marijuana (6.2% THC)

Marijuana cigarette containing 6.2% THC

Intervention Type DRUG

Naltrexone

Naltrexone (12mg/70kg)

Intervention Type DRUG

Placebo naltrexone

Naltrexone (0mg)

Intervention Type DRUG

Other Intervention Names

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Cannabis Cannabis Cannabis Revia PBO

Eligibility Criteria

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Inclusion Criteria

* Current marijuana use
* Able to perform study procedures
* 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, hepatitis, clinically significant laboratory abnormalities, LFTs \> 3x upper limit of normal, blood pressure \> 140/90
Minimum Eligible Age

21 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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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

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Margaret Haney

Clinical Psychaitrist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Margaret Haney, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

New York State Psychiatric Institute

Locations

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New York State Psychiatric Institute

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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DA19239

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IRB# 5693

Identifier Type: -

Identifier Source: org_study_id

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