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

New York State Psychiatric Institute

Status and phase: Completed; Phase 2

Conditions: Marijuana Smoking

Treatments: Drug: Placebo naltrexone; Drug: Active Marijuana (6.2% THC); Drug: Active Marijuana (5.5% THC); Drug: Inactive Marijuana (0% THC); Drug: Naltrexone

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00743145

DA19239 (Other Grant/Funding Number)

IRB# 5693

Details and patient eligibility

About

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.

Enrollment: 23 patients

Sex: All

Ages: 21 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

23 participants in 6 patient groups, including a placebo group

Placebo naltrexone + Inactive marijuana

Placebo Comparator group

Description:

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

Treatment:

Drug: Inactive Marijuana (0% THC)

Drug: Placebo naltrexone

Placebo naltrexone + Active marijuana (5.5% THC)

Placebo Comparator group

Description:

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

Treatment:

Drug: Active Marijuana (5.5% THC)

Drug: Placebo naltrexone

Placebo naltrexone + Active marijuana (6.2% THC)

Placebo Comparator group

Description:

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

Treatment:

Drug: Active Marijuana (6.2% THC)

Drug: Placebo naltrexone

Naltrexone + Active marijuana (5.5% THC)

Experimental group

Description:

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

Treatment:

Drug: Naltrexone

Drug: Active Marijuana (5.5% THC)

Naltrexone + Active marijuana (6.2% THC)

Experimental group

Description:

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

Treatment:

Drug: Naltrexone

Drug: Active Marijuana (6.2% THC)

Naltrexone + Inactive marijuana

Placebo Comparator group

Description:

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

Treatment:

Drug: Naltrexone

Drug: Inactive Marijuana (0% THC)