Prazosin for Smoking Cessation

NCT01642433 | Terminated Phase 2

• 1 other identifier: 071/2011
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Nicotine Dependence

Outcome Measures

Primary Outcomes (1)

• Short-term smoking cessation

  4 days

Study Arms (2)

Sugar pills

PLACEBO COMPARATOR

Drug: Placebo

Prazosin pills

ACTIVE COMPARATOR

Drug: Prazosin

Interventions

Placebo DRUG

Placebo capsules, 3x daily

Sugar pills

Prazosin DRUG

Prazosin medication, 3x daily dosing, up to 15mg/day

Prazosin pills

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre for Addiction and Mental Health: lead
• Ontario Lung Association: collaborator

Study Sites (1)

Centre for Addiction and Mental Health

Toronto, Ontario, Canada

Location

Related Links

• Related Info

MeSH Terms

Conditions

Tobacco Use Disorder

Interventions

Prazosin

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Bernard Le Foll, PhD

  Centre for Addiction and Mental Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Independent Scientist

Study Record Dates

• First Submitted: July 13, 2012
• First Posted: July 17, 2012
• Study Start: July 1, 2012
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: July 16, 2015

Record last verified: 2015-07

Locations

CA (1)