NCT01517165

Pioglitazone to Treat Opioid Withdrawal Symptoms

Terminated Phase 1 Last updated 5 July 2018

What this trial tests

Phase 1 trial testing Pioglitazone in Opioid-Related Disorders in 24 participants. Terminated before completion.

Timeline

4 January 2012

Primary endpoint
2 February 2015

2 February 2015

Quick facts

Lead sponsor	National Institute on Drug Abuse (NIDA)
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Primary purpose	treatment
Enrollment	24
Start date	4 January 2012
Primary completion	2 February 2015
Estimated completion	2 February 2015
Sites	1 location across United States

Drugs / interventions tested

• Pioglitazone (pioglitazone) — full drug profile →
• Placebo

Conditions studied

• Opioid-Related Disorders — all drugs for Opioid-Related Disorders →

Sponsor

National Institute on Drug Abuse (NIDA)

Who can join

Adults 18 to 65, any sex, with Opioid-Related Disorders. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background:

* Opioid-withdrawal symptoms include runny nose, body aches, chills, sweating, and diarrhea. Many people have these symptoms when trying to stop using opioid drugs. Long-acting opioids like methadone and buprenorphine are used to help people stop using other opioids, but these drugs can cause the same withdrawal symptoms. There are no non-opioid drugs that are approved specifically to treat those symptoms.
* Pioglitazone is a drug used to treat type 2 diabetes. In a research study, the drug allowed heroin users to decrease their methadone dose faster without much discomfort, and stay abstinent from heroin. Researchers want to learn more about how pioglitazone helps treat opioid withdrawal symptoms.

Objectives:

\- To test whether pioglitazone can reduce opioid withdrawal symptoms.

Eligibility:

\- Individuals between 18 and 65 years of age who will be using buprenorphine to treat opioid dependency.

Design:

* This study will last up to 17 weeks. Participants must come to the study clinic every day for at least 13 weeks.
* Participants will be screened with a physical exam and medical history. They will also answer questions about drug use habits, and provide blood and urine samples.
* Participants will take buprenorphine daily for 7 weeks. For the first 3 weeks, the dose will be increased to a level that should help stop the use of opioids. For the next 4 weeks, the dose will be decreased. Blood, urine, and breath samples will be collected at different study visits. Participants will also fill out questionnaires about mood, drug craving, and withdrawal symptoms.
* After 1 week on buprenorphine, participants will start the study pill (pioglitazone or a placebo) every day. They will take the study pill for 13 weeks.
* During the treatment period, participants will have drug counseling once a week for 30 minutes.
* Some participants have other tests as part of this study. These tests include functional magnetic resonance imaging scans to look for changes in brain activity and giving samples of cerebrospinal fluid to study brain chemistry.
* Participants will have a final followup phone call 3 weeks after the last clinic visit.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Neuroinflammation in addiction: A review of neuroimaging studies and potential immunotherapies.
   Kohno M, Link J, Dennis LE, McCready H, et al · · 2019 · cited 138× · PMID 30695700 · DOI 10.1016/j.pbb.2019.01.007
2. Assessment of pioglitazone and proinflammatory cytokines during buprenorphine taper in patients with opioid use disorder.
   Schroeder JR, Phillips KA, Epstein DH, Jobes ML, et al · · 2018 · cited 17× · PMID 30079432 · DOI 10.1007/s00213-018-4986-5
3. Therapeutic targeting of neuroinflammation in methamphetamine use disorder.
   Jeffery N, Mock PY, Yang K, Tham CL, et al · · 2025 · cited 3× · PMID 39727147 · DOI 10.1080/17568919.2024.2447226