Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT05610072
EARLY_PHASE1

Behavioral Effects of Drugs (Inpatient): 43 (Opioids, Cocaine, n-Acetylcysteine)

Sponsor: William Stoops

View on ClinicalTrials.gov

Summary

The overarching hypotheses of this protocol are that (1) persistent brain glutamate changes induced by chronic opioid use will exacerbate use of cocaine during opioid physical dependence and withdrawal and (2) n-acetylcysteine (NAC) will ameliorate glutamatergic dysregulation, and thus will reduce both opioid and cocaine demand. These hypotheses will be tested with two specific aims. Specific Aim 1. Determine the reinforcing effects of cocaine in individuals with comorbid opioid and cocaine use disorder with physiological dependence on opioids during NAC maintenance. All subjects will be maintained on oral hydromorphone. They will also be randomly assigned to receive placebo or oral NAC (2.4 g/day), stratified by sex. After dose stabilization, experimental sessions will be conducted in which subjects complete hypothetical cocaine purchase tasks during opioid maintenance and opioid withdrawal. The hypotheses are: 1) cocaine purchasing will be greater during opioid withdrawal and 2) NAC maintenance will attenuate cocaine purchasing across opioid maintenance and withdrawal periods. Specific Aim 2. Evaluate glutamate functionality during periods of opioid maintenance and withdrawal in individuals with comorbid opioid and cocaine use disorder and physiological dependence on opioids during NAC maintenance. Subjects will undergo magnetic resonance spectroscopy to evaluate brain glutamate changes as a function of opioid maintenance/withdrawal state and NAC maintenance. The hypotheses are: 1) glutamate levels will be elevated during opioid withdrawal and 2) NAC maintenance will ameliorate elevated glutamate levels.

Official title: Glutamatergic Mechanisms in Opioid and Cocaine Co-Use

Key Details

Gender

All

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

24

Start Date

2022-12-15

Completion Date

2026-12-31

Last Updated

2025-12-11

Healthy Volunteers

Yes

Interventions

DRUG

n-acetylcysteine

Subjects will be randomized to receive 2.4 oral n-acetylcysteine daily.

DRUG

Hydromorphone

Subjects will receive up to 192 mg oral hydromorphone daily.

DRUG

Placebo n-acetylcystine

Subjects will be randomized to receive placebo n-acetylcysteine daily.

DRUG

Placebo hydromorphone

Prior to some experimental sessions, subjects will receive placebo hydromorphone

Locations (2)

University of Kentucky Laboratory of Human Behavioral Pharmacology

Lexington, Kentucky, United States

University of Kentucky Department of Behavioral Science

Lexington, Kentucky, United States