Prazosin for Smoking Cessation

• Sponsor: Centre for Addiction and Mental Health (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01642433
• Collaborator: Ontario Lung Association (Other)
• Enrollment: 1
• Location: 1
• Arms: 2
• Duration (Months): 14
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Nicotine Dependence	Drug: Placebo; Drug: Prazosin	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 1 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Prazosin as a Novel Treatment for Smoking Cessation
• Study Start Date: Jul 1, 2012
• Actual Primary Completion Date: Sep 1, 2013
• Actual Study Completion Date: Sep 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Sugar pills	Drug: Placebo; Placebo capsules, 3x daily
Active Comparator: Prazosin pills	Drug: Prazosin; Prazosin medication, 3x daily dosing, up to 15mg/day

Outcome Measures

Primary Outcome Measures

1. Short-term smoking cessation [4 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre for Addiction and Mental Health	Toronto	Ontario	Canada

Sponsors and Collaborators

• Centre for Addiction and Mental Health
• Ontario Lung Association

Investigators

• Principal Investigator: Bernard Le Foll, PhD, Centre for Addiction and Mental Health

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info

Publications

None provided.

• Responsible Party: Christian Hendershot, Independent Scientist, Centre for Addiction and Mental Health
• ClinicalTrials.gov Identifier: NCT01642433
• Other Study ID Numbers: 071/2011
• First Posted: Jul 17, 2012
• Last Update Posted: Jul 16, 2015
• Last Verified: Jul 1, 2015

• Additional relevant MeSH terms: Tobacco Use Disorder; Prazosin

Study Results

No Results Posted as of Jul 16, 2015