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Prazosin for Smoking Cessation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01642433
Recruitment Status : Terminated
First Posted : July 17, 2012
Last Update Posted : July 16, 2015
Sponsor:
Collaborator:
Ontario Lung Association
Information provided by (Responsible Party):
Christian Hendershot, Centre for Addiction and Mental Health

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

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Study Type : Interventional  (Clinical Trial)
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 : July 2012
Actual Primary Completion Date : September 2013
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Short-term smoking cessation [ Time Frame: 4 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01642433


Locations
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Canada, Ontario
Centre for Addiction and Mental Health
Toronto, Ontario, Canada
Sponsors and Collaborators
Centre for Addiction and Mental Health
Ontario Lung Association
Investigators
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Principal Investigator: Bernard Le Foll, PhD Centre for Addiction and Mental Health
Additional Information:
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Responsible Party: Christian Hendershot, Independent Scientist, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier: NCT01642433    
Other Study ID Numbers: 071/2011
First Posted: July 17, 2012    Key Record Dates
Last Update Posted: July 16, 2015
Last Verified: July 2015
Additional relevant MeSH terms:
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Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Prazosin
Antihypertensive Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs