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Clinical Trials/NCT01642433
NCT01642433
Terminated
Phase 2

Prazosin as a Novel Treatment for Smoking Cessation

Centre for Addiction and Mental Health1 site in 1 country1 target enrollmentJuly 2012

Overview

Phase
Phase 2
Intervention
Placebo
Conditions
Nicotine Dependence
Sponsor
Centre for Addiction and Mental Health
Enrollment
1
Locations
1
Primary Endpoint
Short-term smoking cessation
Status
Terminated
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 2012
End Date
September 2013
Last Updated
10 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Christian Hendershot

Independent Scientist

Centre for Addiction and Mental Health

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

Arms & Interventions

Sugar pills

Intervention: Placebo

Prazosin pills

Intervention: Prazosin

Outcomes

Primary Outcomes

Short-term smoking cessation

Time Frame: 4 days

Study Sites (1)

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