Clinical trial

Interactions of Alcohol and Opioids: Pharmacodynamic Effects

Name

55176

Description

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.

Trial arms

Trial start

2021-03-24

Estimated PCD

2024-11-01

Trial end

2024-11-01

Status

Recruiting

Phase

Early phase I

Treatment

Alcohol

Active alcohol or placebo, administered orally

Arms:

Alcohol, Opioid Agonist/Alcohol Combination

Opioid Agonist

Active opioid agonist or placebo, administered orally

Arms:

Opioid Agonist, Opioid Agonist/Alcohol Combination

Size

Primary endpoint

Change in Subject-Rated Outcomes

These outcomes (visual analog scores, scale of 0-100) will be recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 6.5 hours per session)

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'This is a randomized, double-blind, double-dummy, placebo-controlled, within-subjects design', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 72, 'type': 'ESTIMATED'}}

Updated at

2023-11-30

1 organization

2 products

2 indications

Organization

Product

Indication

Indication

Product