PPARγ Agonist Treatment for Cocaine Dependence

NCT02774343 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2018-04-26

Study results available
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Summary

The purpose of this research study is to determine whether a medication called pioglitazone (trade name Actos) can reduce behavioral problems associated with cocaine use, improve brain structural changes associated with cocaine use and reduce cocaine craving and drug use in cocaine dependent patients.

Conditions

Interventions

DRUG

Pioglitazone

Subjects randomized to pioglitazone begin with a starting dose of 15 mg daily administered. The dose will be titrated up to 30mg on the second week and 45 mg on the third week of the study. Subjects will remain on 45 mg of pioglitazone until the end of week 12. At the end of week 12 the study medication will be discontinued.

DRUG

Placebo

Subjects randomized to placebo receive placebo capsules once daily across all twelve weeks of the study.

BEHAVIORAL

Therapy

Cognitive-behavioral therapy 1 hour per week

BEHAVIORAL

Contingency Management

Prize-based contingency management for attendance

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 · The University of Texas Health Science Center, Houston

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2015-06-30
Completion
2015-06-30

Countries

  • United States

Study Locations

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Entities

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 NCT02774343 on ClinicalTrials.gov