PPARγ Agonist Treatment for Cocaine Dependence

NCT ID: NCT02774343

Last Updated: 2018-04-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2015-06-30

Brief 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

Cocaine Use Disorder; Alcohol Use Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Pioglitazone + Therapy + Contingency Management

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.

Group Type: EXPERIMENTAL

Pioglitazone

Intervention Type: DRUG

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.

Therapy

Intervention Type: BEHAVIORAL

Cognitive-behavioral therapy 1 hour per week

Contingency Management

Intervention Type: BEHAVIORAL

Prize-based contingency management for attendance

Placebo + Therapy + Contingency Management

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Therapy

Intervention Type: BEHAVIORAL

Cognitive-behavioral therapy 1 hour per week

Contingency Management

Intervention Type: BEHAVIORAL

Prize-based contingency management for attendance

Interventions

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.

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Therapy

Cognitive-behavioral therapy 1 hour per week

Intervention Type: BEHAVIORAL

Contingency Management

Prize-based contingency management for attendance

Intervention Type: BEHAVIORAL

Other Intervention Names

Actos; corn starch

Eligibility Criteria

Inclusion Criteria

• DSM-IV criteria for cocaine dependence
• At least one cocaine positive urine during screening
• Female subjects: a negative pregnancy test
• Be in acceptable health on the basis of interview, medical history and physical exam
• Be able to understand the consent form and provide written informed consent
• Be able to provide the names of at least 2 persons who can generally locate their whereabouts.

Exclusion Criteria

• Current Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV diagnosis of any psychoactive substance dependence other than cocaine marijuana, alcohol, or nicotine
• Any serious medical or psychiatric illness and/or clinically significant abnormal laboratory value, which in the judgment of the Principal Investigator or his/her designee would make study participation unsafe, or would make treatment compliance difficult or put the study staff at undue risk
• Significant current suicidal or homicidal ideation
• Medical conditions contraindicating pioglitazone pharmacotherapy (e.g., congestive heart failure as determined by Framingham criteria, clinically significant edema, clinically significant liver disease, hypoglycemia, diabetes, history of bladder cancer)
• Taking medications known to have significant drug interactions with the study medication (CYP2C8 inhibitors or inducers, antihyperglycemic medications)
• Currently being treated for substance misuse with medication
• Conditions of probation or parole requiring reports of drug use to officers of the court
• Impending incarceration
• Pregnant or planning to become pregnant during the course of the trial or nursing for female patients
• Inability to read, write, or speak English (many of the research instruments in this study only exist in English)
• Having plans to leave the immediate geographical area within 3 months
• Unwillingness to sign a written informed consent form
• Unwillingness to use a barrier method of birth control during the study for female patients
• History of pacemaker or metal implants or welding or metal work without protective eyewear (for risk of MRI scans).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role: lead

Responsible Party

Joy Schmitz

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joy M Schmitz, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

The University of Texas Health Science Center at Houston

Houston, Texas, United States

Countries

United States

Other Identifiers

P50DA009262

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HSC-MS-12-0421

Identifier Type: -

Identifier Source: org_study_id