Trial Outcomes & Findings for Pioglitazone for Heroin and for Nicotine Dependence (NCT NCT01395797)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

82 participants

Primary outcome timeframe

Following 2 weeks of Pioglitazone (PIO) maintenance.

Results posted on

2017-07-13

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo - Heroin Control condition for active arms. Placebo: Placebo - Heroin	Pio Low Dose - Heroin Low dose pio comparator. Pioglitazone: 0, 15, and 45 mg per day.	Pio High Dose - Heroin High dose pio comparator. Pioglitazone: 0, 15, and 45 mg per day.	Placebo - Nicotine Control condition for active arms. Pioglitazone: 0, 15, and 45 mg per day.	Pio Low Dose - Nicotine Low dose pio comparator. Pioglitazone: 0, 15, and 45 mg per day.	Pio High Dose - Nicotine High dose pio comparator. Pioglitazone: 0, 15, and 45 mg per day.
Overall Study STARTED	19	4	18	15	9	17
Overall Study COMPLETED	16	3	14	13	7	14
Overall Study NOT COMPLETED	3	1	4	2	2	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pioglitazone for Heroin and for Nicotine Dependence

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo - Heroin n=19 Participants Control condition for active arms. Placebo: Placebo - Heroin	Pio Low Dose - Heroin n=4 Participants Low dose pio comparator. Pioglitazone: 0, 15, and 45 mg per day.	Pio High Dose - Heroin n=18 Participants High dose pio comparator. Pioglitazone: 0, 15, and 45 mg per day.	Placebo - Nicotine n=15 Participants Control condition for active arms. Pioglitazone: 0, 15, and 45 mg per day.	Pio Low Dose - Nicotine n=9 Participants Low dose pio comparator. Pioglitazone: 0, 15, and 45 mg per day.	Pio High Dose - Nicotine n=17 Participants High dose pio comparator. Pioglitazone: 0, 15, and 45 mg per day.	Total n=82 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Age, Categorical Between 18 and 65 years	19 Participants n=5 Participants	4 Participants n=7 Participants	18 Participants n=5 Participants	15 Participants n=4 Participants	9 Participants n=21 Participants	17 Participants n=8 Participants	82 Participants n=8 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	1 Participants n=21 Participants	2 Participants n=8 Participants	7 Participants n=8 Participants
Sex: Female, Male Male	19 Participants n=5 Participants	4 Participants n=7 Participants	16 Participants n=5 Participants	13 Participants n=4 Participants	8 Participants n=21 Participants	15 Participants n=8 Participants	75 Participants n=8 Participants
Region of Enrollment United States	19 participants n=5 Participants	4 participants n=7 Participants	18 participants n=5 Participants	15 participants n=4 Participants	9 participants n=21 Participants	17 participants n=8 Participants	82 participants n=8 Participants

PRIMARY outcome

Timeframe: Following 2 weeks of Pioglitazone (PIO) maintenance.

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.

Outcome measures

Outcome measures
Measure	Placebo - Heroin n=16 Participants Control condition for active arms. Placebo: Placebo - Heroin	Pio Low Dose- Heroin n=3 Participants Low dose of Pio comparator	Pio High Dose - Heroin n=14 Participants High dose pio comparator. Pioglitazone: 0, 15, and 45 mg per day.	Placebo - Nicotine n=13 Participants Control condition for active arms. Pioglitazone: 0, 15, and 45 mg per day.	Pio Low Dose- Nicotine n=7 Participants Low dose Pio comparator.	Pio High Dose - Nicotine n=14 Participants High dose pio comparator. Pioglitazone: 0, 15, and 45 mg per day.
Drug's Break Point	1037 Mouse clicks Standard Deviation 1763	1200 Mouse clicks Standard Deviation 272	2014 Mouse clicks Standard Deviation 2835	568 Mouse clicks Standard Deviation 652	722 Mouse clicks Standard Deviation 823	960 Mouse clicks Standard Deviation 1004

SECONDARY outcome

Timeframe: Following 2 weeks of Pioglitazone (PIO) maintenance.

Visual analog scale ratings of "Liking" reported by the participant will be the primary endpoint (0-100 mm, 0=Not at all, 100=Extremely).