The Behavioral Effects of Opioids and Alcohol

Sharon Walsh

Status and phase: Completed; Phase 1

Conditions: Opioid Use; Alcohol Drinking

Treatments: Drug: Alcohol; Drug: Opioid Agonist

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04300751

55176

R01DA016718 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

This study will examine the effects of doses of alcohol/placebo and doses of opioid/placebo, alone and in combination. The primary outcomes are related to pharmacodynamic measures (subjective ratings of drug liking and other abuse-related effects; physiological outcomes) to determine the interaction effects of these compounds.

Enrollment: 11 patients

Sex: All

Ages: 21 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy adults ages 21-55
• Current non-medical use of opioids
• Previous alcohol use

Exclusion criteria

• Physical dependence on opioids, alcohol, or benzodiazepines/sedative/hypnotics
• Seeking treatment for drug use
• Significant medical problems

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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11 participants in 3 patient groups

Alcohol

Experimental group

Description:

Participants will receive experimental doses of active or placebo alcohol, p.o. Alcohol/placebo will be administered once per session.

Treatment:

Drug: Alcohol

Opioid Agonist

Experimental group

Description:

Participants will receive non-therapeutic, experimental doses of an active opioid agonist or placebo. Active opioid agonist/placebo will be administered once per session and will be administered orally

Treatment:

Drug: Opioid Agonist

Opioid Agonist/Alcohol Combination

Experimental group

Description:

Participants will receive non-therapeutic, experimental doses of active opioid/placebo in combination with experimental doses of active alcohol placebo. Opioid/placebo and alcohol/placebo doses will be administered once during each session. It is possible to receive both active drugs on the same day. Both opioid and alcohol doses will be administered orally.

Treatment:

Drug: Opioid Agonist

Drug: Alcohol