Pioglitazone for Heroin and for Nicotine Dependence

New York State Psychiatric Institute

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Heroin Dependence; Nicotine Dependence

Treatments: Drug: Placebo; Drug: PIO

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT01395797

6255

R01DA031022 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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 (PPARγ) agonist, will be used as an adjunct to agonist-based treatment.

Full 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.

Enrollment: 82 patients

Sex: All

Ages: 21 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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82 participants in 6 patient groups, including a placebo group

Placebo - Heroin

Placebo Comparator group

Description:

Participants will be maintained on 0 mg of Pioglitazone (PIO) prior to sessions assessing the abuse liability of heroin.

Treatment:

Drug: Placebo

PIO low dose - Heroin

Experimental group

Description:

Participants will be maintained on 15 mg of PIO prior to sessions assessing the abuse liability of heroin.

Treatment:

Drug: PIO

PIO high dose - Heroin

Experimental group

Description:

Participants will be maintained on 45 mg of PIO prior to sessions assessing the abuse liability of heroin.

Treatment:

Drug: PIO

Placebo - Nicotine

Placebo Comparator group

Description:

Participants will be maintained on 0 mg of PIO prior to sessions assessing the abuse liability of nicotine.

Treatment:

Drug: PIO

PIO Low Dose - Nicotine

Experimental group

Description:

Participants will be maintained on 15 mg of PIO prior to sessions assessing the abuse liability of nicotine

Treatment:

Drug: PIO

PIO High Dose - Nicotine

Experimental group

Description:

Participants will be maintained on 45 mg of PIO prior to sessions assessing the abuse liability of nicotine

Treatment:

Drug: PIO