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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01395797
Other study ID # 6255
Secondary ID R01DA031022
Status Terminated
Phase Phase 1/Phase 2
First received July 13, 2011
Last updated July 11, 2017
Start date March 2011
Est. completion date June 2014

Study information

Verified date July 2017
Source New York State Psychiatric Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of the proposed research is to improve the effectiveness of treatments for opioid and for nicotine dependence by testing a novel pharmacological strategy. Specifically, pioglitazone, a peroxisome proliferator-activated gamma receptor (PPARĪ³) agonist, will be used as an adjunct to agonist-based treatment.


Description:

Although treatments for opioid and for nicotine dependence exist, these medications are not universally effective as many patients are unable to stop using or relapse rapidly, suggesting that treatment with a single agent alone is insufficient to facilitate cessation of use in many patients. Targeting additional pathways that may contribute to the maintenance of drug-taking behaviors or relapse may be a more effective strategy to treat individuals resistant to first-line approaches.


Recruitment information / eligibility

Status Terminated
Enrollment 82
Est. completion date June 2014
Est. primary completion date April 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 21 Years to 55 Years
Eligibility Inclusion Criteria:

- 21-55 years of age

- Physically healthy

- Able to perform study procedures

Exclusion Criteria:

- Pregnancy

- Physical dependence on any other drugs besides caffeine, heroin and nicotine

Study Design


Intervention

Drug:
PIO
0, 15, and 45 mg per day.
Placebo
Placebo

Locations

Country Name City State
United States New York State Psychiatric Institute New York New York

Sponsors (3)

Lead Sponsor Collaborator
New York State Psychiatric Institute National Institute on Drug Abuse (NIDA), Omeros Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Drug's Break Point Number of operant responses (mouse clicks) participants were willing to provide in order to receive the drug under investigation (heroin or nicotine). The Breakpoint is the point at which participants stopped responding for the drug, i.e., the total number of clicks they were willing to provide in order to receive the drug. Following 2 weeks of Pioglitazone (PIO) maintenance.
Secondary Measures of Subjective Drug Effects Most Commonly Indicative of Abuse Liability. Visual analog scale ratings of "Liking" reported by the participant will be the primary endpoint (0-100 mm, 0=Not at all, 100=Extremely). Following 2 weeks of Pioglitazone (PIO) maintenance.
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