Clinical trial

Prescription Medications: Pharmacodynamics and Interaction Effects

Name

46591

Description

This study will examine the effects of doses of opioid/placebo and doses of sedative/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

2019-03-25

Estimated PCD

2023-05-06

Trial end

2023-05-06

Status

Completed

Phase

Early phase I

Treatment

Opioid Agonist

Active opioid agonist or placebo, administered orally

Arms:

Opioid agonist/sedative, Oral opioid agonist

Sedatives

Active sedative or placebo, administered orally

Arms:

Opioid agonist/sedative, Oral sedative

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. 8 hours per session).

Eligibility criteria

Inclusion Criteria: * Healthy adults, ages 18-55 * Current non-medical use of opioids and sedatives Exclusion Criteria: * Physical dependence on opioids, alcohol, or benzodiazepines/sedatives/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 design', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 28, 'type': 'ACTUAL'}}

Updated at

2024-01-26

1 organization

2 products

2 indications

Organization

Product

Indication

Indication

Product