Clinical trial

Modulation of Drug Intake: Evaluation of Opioid and Cannabinoid Interactions on Drug Self-Administration

Name

45017-20221

Description

The primary goals of this study are to examine 1) marijuana modulation of oxycodone self-administration and 2) oxycodone modulation of marijuana self-administration, under controlled conditions and across a range of doses for each drug.

Trial arms

Trial start

2023-08-03

Estimated PCD

2025-09-01

Trial end

2025-10-01

Status

Recruiting

Phase

Early phase I

Treatment

Marijuana

Double-blind administration of marijuana

Arms:

Double-blind marijuana/placebo administration, Double-blind opioid/placebo administration

Other names:

Cannabis

Opioid

Double-blind administration of an opioid agonist

Arms:

Double-blind marijuana/placebo administration, Double-blind opioid/placebo administration

Size

Primary endpoint

Self-Administration

Collected once during each self-administration session

Eligibility criteria

Inclusion Criteria: * Ages 18-50 * Experience with marijuana and opioids * General good health * Willing to live at the University of Kentucky Hospital (research unit) for approx. 6.5 weeks (meals are provided, Exclusion Criteria: * Significant medical complications/conditions

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 12, 'type': 'ESTIMATED'}}

Updated at

2023-10-30

1 organization

2 products

2 indications

Organization

Shanna Babalonis, PhD

Product

Indication

Indication

Product