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Pioglitazone + Cognitive-Behavioral Therapy for Cocaine Use Disorder

Phase 2
Recruiting
Led By Joy M Schmitz, PhD
Research Sponsored by The University of Texas Health Science Center, Houston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
18 to 65 years old
18 to 60 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from week 10 to week 12
Awards & highlights

Study Summary

This trial will test how well pioglitazone, used with cognitive behavioral therapy, can help people who have recently stopped using cocaine to stay cocaine-free.

Who is the study for?
This trial is for adults aged 18-65 who have recently used cocaine, as confirmed by a drug test. Participants must be physically and mentally stable, understand the consent form, agree to use effective birth control if female and not pregnant or breastfeeding. They should also commit to a 5-day detox program and provide contacts for locating them.Check my eligibility
What is being tested?
The study tests whether pioglitazone combined with cognitive-behavioral therapy (CBT) can help prevent relapse in individuals recovering from cocaine use disorder. Participants will either receive pioglitazone or a placebo alongside CBT sessions.See study design
What are the potential side effects?
Pioglitazone may cause side effects like fluid retention leading to swelling, weight gain, fatigue, headache, muscle pain; it could also potentially worsen any heart problems or increase the risk of bladder cancer.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 65 years old.
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I am between 18 and 60 years old.
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I am willing to join a 5-day detox program at The Right Step Houston.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from week 10 to week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and from week 10 to week 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in attention/impulsivity as assessed by the NIH Toolbox Cognition Battery Flanker Test
Body Weight Changes
Change in white matter integrity as assessed by change in fractional anisotropy value measured by diffusion tensor imaging
+5 more
Secondary outcome measures
Functional health status as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) global health summary score
Total percentage of cocaine-negative urine drug screens during treatment as assessed by number of cocaine-negative samples out of total number of urine samples provided
Total percentage of days abstinent during treatment as assessed by self-reported non-use days confirmed by cocaine-negative urine drug screen results

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: CBT + pioglitazoneActive Control2 Interventions
Cognitive Behavioral Therapy will be administered twice weekly during weeks 1-4 and once weekly during weeks 5-12 and augmented with a pioglitazone (45 mg) capsule every day during weeks 1-12.
Group II: CBT + placeboPlacebo Group2 Interventions
Cognitive Behavioral Therapy will be administered twice weekly during weeks 1-4 and once weekly during weeks 5-12 and augmented with a placebo capsule every day during weeks 1-12.

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center, HoustonLead Sponsor
904 Previous Clinical Trials
320,900 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,470 Previous Clinical Trials
2,619,670 Total Patients Enrolled
Joy M Schmitz, PhDPrincipal InvestigatorUT Houston
5 Previous Clinical Trials
456 Total Patients Enrolled

Media Library

Cognitive Behavioral Therapy (CBT) Clinical Trial Eligibility Overview. Trial Name: NCT04843046 — Phase 2
Cocaine Use Disorder Research Study Groups: CBT + pioglitazone, CBT + placebo
Cocaine Use Disorder Clinical Trial 2023: Cognitive Behavioral Therapy (CBT) Highlights & Side Effects. Trial Name: NCT04843046 — Phase 2
Cognitive Behavioral Therapy (CBT) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04843046 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any other research projects that have looked at CBT in combination with pioglitazone?

"At the moment, there are a total of 34 different clinical trials testing CBT + pioglitazone. Out of these tests, 5 are in Phase 3. The city with the most ongoing trials is Lausanne, Vaud; however, there are 72 locations worldwide where at least one trial is taking place."

Answered by AI

Is the age limit for participants in this research over 30 years old?

"The target recruitment pool for this study are adults aged 18 to 60."

Answered by AI

How many total subjects are a part of this investigation?

"That is accurate, the online registry shows that this trial is still recruiting patients. This study was originally posted on August 23rd 2021 and was most recently updated on June 7th of this year. They are looking for a total of 60 individuals across 1 location."

Answered by AI

Are there any available positions for patients who want to enroll in this trial?

"Per clinicaltrials.gov, this study is still recruiting patients as of 6/7/2022. The trial was originally posted on 8/23/2021."

Answered by AI

What psychological disorder and diabetes medication are often used together in treatment?

"CBT + pioglitazone is not only an effective treatment for diabetes, but also other conditions like diabetic neuralgia. Furthermore, this combination therapy can help patients better adhere to their diet and exercise regimens."

Answered by AI

Could I potentially qualify to join this clinical trial?

"The ideal candidate for this medical trial is somebody who has relapsed and is between 18-60 years old. A total of 60 patients are needed for the study."

Answered by AI

Has the FDA ruled on CBT + pioglitazone for patient use?

"Our team at Power estimates that the safety of CBT + pioglitazone is a 2 on a scale from 1 to 3. This is because this is a Phase 2 trial, meaning there is some data supporting safety but none supporting efficacy."

Answered by AI

Who else is applying?

What state do they live in?
Pennsylvania
Texas
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
UTHealth Center for Neurobehavioral Research on Addiction
Recent research and studies
clinicaltrials.govStudy
Pioglitazone as an Adjunct to Cognitive-Behavioral Therapy for Cocaine Relapse Prevention
Joy Schmitz 2021. "Pioglitazone as an Adjunct to Cognitive-Behavioral Therapy for Cocaine Relapse Prevention". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04843046.
~19 spots leftby Aug 2025
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