Prazosin for Smoking Cessation

This study has been terminated.
Sponsor:
Collaborator:
Ontario Lung Association
Information provided by (Responsible Party):
Christian Hendershot, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier:
NCT01642433
First received: July 13, 2012
Last updated: April 22, 2013
Last verified: April 2013
  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

Resource links provided by NLM:


Further study details as provided by Centre for Addiction and Mental Health:

Primary Outcome Measures:
  • 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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01642433

Locations
Canada, Ontario
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
  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 July 24, 2014