Prazosin for Smoking Cessation
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Nicotine Dependence |
Drug: Placebo Drug: Prazosin |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Prazosin as a Novel Treatment for Smoking Cessation |
- Short-term smoking cessation [ Time Frame: 4 days ] [ Designated as safety issue: No ]
| Enrollment: | 1 |
| Study Start Date: | July 2012 |
| Estimated Study Completion Date: | September 2013 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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
|
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| 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| Canada, Ontario | |
| Centre for Addiction and Mental Health | |
| Toronto, Ontario, Canada | |
| Principal Investigator: | Bernard Le Foll, PhD | Centre for Addiction and Mental Health |
More Information
Additional Information:
No publications provided
| Responsible Party: | Christian Hendershot, Independent Scientist, Centre for Addiction and Mental Health |
| ClinicalTrials.gov Identifier: | NCT01642433 History of Changes |
| Other Study ID Numbers: | 071/2011 |
| Study First Received: | July 13, 2012 |
| Last Updated: | April 22, 2013 |
| Health Authority: | Canada: Health Canada |
Additional relevant MeSH terms:
|
Tobacco Use Disorder Substance-Related Disorders Mental Disorders Prazosin Antihypertensive Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions |
Adrenergic alpha-1 Receptor Antagonists Adrenergic alpha-Antagonists Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 16, 2013