PPARγ Agonist Treatment for Cocaine Dependence

The University of Texas System (UT)

Status and phase: Completed; Phase 2; Phase 1

Conditions: Cocaine Use Disorder; Alcohol Use Disorder

Treatments: Behavioral: Contingency Management; Behavioral: Therapy; Drug: Placebo; Drug: Pioglitazone

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02774343

HSC-MS-12-0421

P50DA009262 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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30 participants in 2 patient groups, including a placebo group

Pioglitazone + Therapy + Contingency Management

Experimental group

Description:

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.

Treatment:

Behavioral: Contingency Management

Drug: Pioglitazone

Behavioral: Therapy

Placebo + Therapy + Contingency Management

Placebo Comparator group

Description:

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

Treatment:

Behavioral: Contingency Management

Drug: Placebo

Behavioral: Therapy