Prazosin for Smoking Cessation

Nicotine Dependence Clinical Trial

Official title:

Prazosin as a Novel Treatment for Smoking Cessation

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01642433
• Other study ID #: 071/2011
• Status: Terminated
• Phase: Phase 2
• First received: July 13, 2012
• Last updated: July 15, 2015
• Start date: July 2012
• Est. completion date: September 2013

Study information

• Verified date: July 2015
• Source: Centre for Addiction and Mental Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Nicotine Dependence

Intervention

Drug:
• Placebo
Placebo capsules, 3x daily
• Prazosin
Prazosin medication, 3x daily dosing, up to 15mg/day

Locations

Country	Name	City	State
Canada	Centre for Addiction and Mental Health	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Centre for Addiction and Mental Health	Ontario Lung Association

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Short-term smoking cessation		4 days	No

External Links

•   Link