Prazosin for Smoking Cessation
Primary Purpose
Nicotine Dependence
Status
Terminated
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Placebo
Prazosin
Sponsored by
About this trial
This is an interventional treatment trial for Nicotine Dependence
Eligibility Criteria
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
Sites / Locations
- Centre for Addiction and Mental Health
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Sugar pills
Prazosin pills
Arm Description
Outcomes
Primary Outcome Measures
Short-term smoking cessation
Secondary Outcome Measures
Full Information
NCT ID
NCT01642433
First Posted
July 13, 2012
Last Updated
July 15, 2015
Sponsor
Centre for Addiction and Mental Health
Collaborators
Ontario Lung Association
1. Study Identification
Unique Protocol Identification Number
NCT01642433
Brief Title
Prazosin for Smoking Cessation
Official Title
Prazosin as a Novel Treatment for Smoking Cessation
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Terminated
Study Start Date
July 2012 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre for Addiction and Mental Health
Collaborators
Ontario Lung Association
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nicotine Dependence
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sugar pills
Arm Type
Placebo Comparator
Arm Title
Prazosin pills
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo capsules, 3x daily
Intervention Type
Drug
Intervention Name(s)
Prazosin
Intervention Description
Prazosin medication, 3x daily dosing, up to 15mg/day
Primary Outcome Measure Information:
Title
Short-term smoking cessation
Time Frame
4 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bernard Le Foll, PhD
Organizational Affiliation
Centre for Addiction and Mental Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre for Addiction and Mental Health
City
Toronto
State/Province
Ontario
Country
Canada
12. IPD Sharing Statement
Links:
URL
http://www.camh.net/research
Description
Related Info
Learn more about this trial
Prazosin for Smoking Cessation
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