Prazosin for Smoking Cessation

Phase 2

Terminated

• Conditions: Nicotine Dependence
• Interventions: Drug: Prazosin; Drug: Placebo

• Registration Number: NCT01642433
• Lead Sponsor: Centre for Addiction and Mental Health

Brief Summary

The most likely outcome of smoking cessation attempts is relapse, underscoring the need to advance novel treatments. Preclinical research shows that the noradrenergic system is critical for modulating drug-seeking behavior and recent findings indicate that the α1-adrenergic antagonist prazosin reduces nicotine self-administration and reinstatement. Presently, data on prazosin's effects on nicotine-related behaviour in humans is lacking. An efficient method for screening novel smoking cessation medications is to integrate human laboratory paradigms in the context of brief, randomized trials of smoking cessation that include smokers motivated to quit. This study aims to provide an initial test of prazosin for smoking cessation by implementing a brief, randomized trial that will include both human laboratory and clinical phenotypes. This approach will allow an efficient but sensitive method for medication screening that maximizes clinical validity.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-07-13
• Study First Submitted QC: 2012-07-16
• Study First Posted: 2012-07-17
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-15
• Last Update Posted: 2015-07-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

• Greater than or equal to 10 cigarettes per day for past year
• Baseline Fagerstrom Test for Nicotine Dependence (FTND) score of greater than or equal to four
• Willing to engage in two practice quit attempts
• Willingness to forgo other medication based treatments during the trial

Exclusion Criteria

• Current illicit drug use
• Current treatment with psychiatric medications other than selective serotonin re-uptake inhibitors (SSRIs)
• Lifetime diagnosis of post-traumatic stress disorder (PTSD)
• Significant medical/neurological illness
• Baseline BP outside of normal range
• Current use of tobacco aids
• Current use of medications that could interact with prazosin
• Pregnancy or nursing

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Prazosin pills	Prazosin	-
Sugar pills	Placebo	-

Primary Outcome Measures

Name	Time	Method
Short-term smoking cessation	4 days

Trial Locations

Locations (1)

Centre for Addiction and Mental Health; 🇨🇦 Toronto, Ontario, Canada