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Pioglitazone as an Adjunct to Cognitive-Behavioral Therapy for Cocaine Relapse Prevention

NCT04843046 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2026-04-01

No results posted yet for this study

Summary

The purpose of this study is to see how well pioglitazone, when used with cognitive behavioral therapy, works at helping people who have recently stopped using cocaine to continue to not use cocaine.

Conditions

  • Cocaine Use Disorder

Interventions

BEHAVIORAL

Cognitive Behavioral Therapy (CBT)

All participants will receive evidence-based individual Cognitive Behavioral Therapy (CBT) shown to be an effective intervention for maintaining abstinence following detoxification. Trained masters-level licensed professional counselors will deliver CBT.

DRUG

Pioglitazone

Pioglitazone capsules will start at 30 mg (Detox days 3 and 4) and increase to fixed dose of 45 mg for study weeks 1-12 and will also contain riboflavin.

DRUG

Placebo

Placebo capsules will be filled with corn starch and riboflavin.

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • The University of Texas Health Science Center, Houston

    lead OTHER

Principal Investigators

  • Joy M Schmitz, PhD · UT Houston

  • Scott D Lane, PhD · UT Houston

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-23
Primary Completion
2025-09-26
Completion
2025-10-15
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04843046 on ClinicalTrials.gov