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TerminatedNCT01642433Updated Jul 16, 2015

Prazosin for Smoking Cessation

A Phase 2 interventional study of Placebo and Prazosin in Nicotine Dependence, sponsored by Centre for Addiction and Mental Health. Terminated at 1 site in Canada. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-07-16.

Sponsored by Centre for Addiction and Mental Health · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
1
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

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Conditions studied

  • Nicotine Dependence

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03

In context

Tobacco Use Disorder

988 studies on the registry are indexed under Tobacco Use Disorder; 125 are open to participants now.

This study's enrollment of 1 is below the median of 90 across 863 interventional studies indexed under Tobacco Use Disorder.

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Lead sponsor

Centre for Addiction and Mental Health is the lead sponsor of 339 studies on the registry; 51 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
1 participant (actual)

Study arms

  • Placebo comparator
    Sugar pills

    Drug: Placebo

  • Active comparator
    Prazosin pills

    Drug: Prazosin

Interventions

  • DrugPlacebo

    Placebo capsules, 3x daily

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

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What researchers measure

Primary outcomes

  1. Short-term smoking cessation

    Time frame: 4 days

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Study locations

1 site
  • Centre for Addiction and Mental Health
    Toronto, Ontario, Canada
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References and documents

Related links

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 16, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01642433
Collaborators
Ontario Lung Association
Responsible party
Christian Hendershot (Independent Scientist, Centre for Addiction and Mental Health) — Principal investigator
First posted
Jul 17, 2012
Start date
Jul 2012
Primary completion
Sep 2013
Completion
Sep 2013
Last update
Jul 16, 2015

Study contacts

Bernard Le Foll, PhD
principal investigator · Centre for Addiction and Mental Health

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Prazosin

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