Pioglitazone to Treat Opioid Withdrawal Symptoms

Stopped early · Phase 1 · Has a placebo group

Conditions studied: Opioid-Related Disorders

In brief

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.

Key facts

Study ID: NCT01517165
Run by: National Institute on Drug Abuse (NIDA)
People needed: 24
Starts: 2012-01-04
Expected to finish: 2015-02-02
Last updated by the study team: 2018-07-05

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may not qualify if…

Any medical illness that in the view of the investigators would compromise participation in research (determined by Medical History; Physical Examination; Blood and Urine Laboratory tests; see details under Screening measures below), including, but not limited to:
Diabetes mellitus Type I or Type II
Past or current diagnosis of congestive heart failure
Signs and symptoms consistent with congestive heart failure including but not limited to fatigue, exercise intolerance, decreased peripheral perfusion, orthopnea, dyspnea on exertion, paroxysmal nocturnal dyspnea, peripheral edema, elevated jugular-venous pressure, pleural and pericardial effusions, hepatic congestion, ascites, elevated BUN and creatinine, hyponatremia, and elevated serum levels of hepatic enzymes.
Cardiovascular disease (e.g., history of congenital heart defect, heart disease, symptomatic coronary-artery disease, heart attack, irregular heartbeat, etc.)
Cerebrovascular disease
Unexplained history of syncope
History of seizures, except for febrile seizures at childhood
History of head injury with loss of consciousness of more than 30 minutes or with postconcussive sequelae lasting more than two days, regardless of loss of consciousness
Chronic renal failure as estimated by glomerular filtration rate (GFR) <60 mL/min/1.73 m(2)
CD4 < 200 or evidence of severely compromised immune system /AIDS
Active bladder cancer or history of bladder cancer
Allergy, hypersensitivity, or intolerance to buprenorphine, pioglitazone, other TZDs, or the metabolites of any of those drugs (determined by Medical History)
Pregnancy or breastfeeding (Urine Pregnancy Test; self-report)
Diabetes medications (e.g., sulfonylureas, metformin, insulin, etc.)
Contraindicated medications (Medical History): Gemfibrozil (inhibitor of CYP2C8) and Rifampin (inducer of CYP2C8), atorvastatin, ketoconazole, nifedipine, topiramate, and diazepam.
Psychiatric history:
A) Cognitive impairment severe enough to preclude informed consent or valid responses on questionnaires
B) Current diagnosis of: schizophrenia or any other DSM-IV psychotic disorder, bipolar disorder, or Major Depressive Disorder (Self-Report; SCID Screen Patient Questionnaire
Extended (SSPQ-X))
Current physical dependence on alcohol or sedative-hypnotics, e.g. benzodiazepines (self-report; ASI; alcohol CAGE questions; and pattern of positive drug screens or BAL for alcohol)
Body Mass Index (BMI) of 40 or higher
Additional Exclusion Criteria for the fMRI portion of the Study:
Exclusion from the MRI component of the study will be based on the criteria outlined below. Participants who do not qualify or who do not agree to participate in the fMRI portion of the study will not be excluded from the main study. Exclusion criteria will be assessed during screening under NIDA-IRP screening protocol 06-DA-N415. Participants will be excluded from the fMRI portion of the study if they:
are left handed. Justification: Some of the neural processes assessed in this protocol may be lateralized in the brain. In order to reduce potential variance, participants will be required to be right-handed. Assessment tool(s): Edinburgh Handedness Inventory.

Where it is running

National Institute on Drug Abuse — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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