Clinical trial NCT02774343: PPARγ Agonist Treatment for Cocaine Dependence
Official title: PPARγ Agonist Treatment for Cocaine Dependence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Cocaine Use Disorder
Alcohol Use Disorder
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2016-05-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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).

Primary outcomes:
measure: Craving as Assessed by the Brief Substance Craving Scale (BSCS)
timeFrame: Baseline, week 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8, week 9, week 10, week 11, week 12
measure: Craving as Assessed by the Obsessive Compulsive Drug Use Scale (OCDUS)
timeFrame: Weeks 1-12
measure: Cue Reactivity as Assessed by a Visual Analogue Scale (VAS) of Cocaine Craving
timeFrame: Baseline, week 2, week 4, week 6, week 8, week 10, week 12
measure: Brain White Matter (WM) Integrity as Assessed by Diffusion Tensor Imaging (DTI) Fractional Anisotropy (FA) Value (Region - Posterior Thalamic Radiation)
timeFrame: Baseline and Week 12
measure: Brain White Matter (WM) Integrity as Assessed by Diffusion Tensor Imaging (DTI) Fractional Anisotropy (FA) Value (Region - Anterior Thalamic Radiation)
timeFrame: Baseline and Week 12
measure: Brain White Matter (WM) Integrity as Assessed by Diffusion Tensor Imaging (DTI) Fractional Anisotropy (FA) Value (Region - Splenium of Corpus Callosum)
timeFrame: Baseline and Week 12
measure: Brain White Matter (WM) Integrity as Assessed by Diffusion Tensor Imaging (DTI) Fractional Anisotropy (FA) Value (Region - Genu of Corpus Callosum)
timeFrame: Baseline and Week 12
measure: Brain White Matter (WM) Integrity as Assessed by Diffusion Tensor Imaging (DTI) Fractional Anisotropy (FA) Value (Region - External Capsule)
timeFrame: Baseline and Week 12
measure: Brain White Matter (WM) Integrity as Assessed by Diffusion Tensor Imaging (DTI) Fractional Anisotropy (FA) Value (Region - Cingulum)
timeFrame: Baseline and Week 12
Secondary outcomes:
measure: Feasibility - Subject Retention as Assessed by Number of Participants Who Completed All 12 Weeks of the Study
timeFrame: week 12
measure: Feasibility - Medication Compliance as Assessed by Percentage of Urine Samples That Were Riboflavin-Positive
timeFrame: weeks 1 - 12
measure: Feasibility - Medication Compliance as Assessed by Percentage of Self-reports That Indicate Capsules Were Taken
timeFrame: weeks 1 - 12
measure: Feasibility - Tolerability as Assessed by Number of Participants Reporting Side Effects
timeFrame: week 12
measure: Feasibility - Tolerability as Assessed by Number of Participants With Serious Adverse Events
timeFrame: week 12
measure: Cocaine Use as Assessed by Percentage of Urine Samples That Were Cocaine-positive
timeFrame: Weeks 1-12
measure: Cocaine Use as Assessed by Percentage of Self-reports That Indicate Cocaine Use
timeFrame: Weeks 1-12
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Joy M Schmitz, PhD
role: PRINCIPAL_INVESTIGATOR
References: