NCT01730846

Brief Summary

The purpose of this study is to examine whether doxazosin will attenuate the ability of stress to precipitate smoking lapse behavior in treatment seeking daily smokers. Participants will participate in a smoking cessation attempt after the laboratory sessions.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Feb 2013

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 9, 2012

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 21, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2013

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

December 20, 2017

Completed
Last Updated

February 20, 2018

Status Verified

January 1, 2018

Enrollment Period

3.8 years

First QC Date

November 9, 2012

Results QC Date

November 20, 2017

Last Update Submit

January 22, 2018

Conditions

Smoking

Keywords

smoking lapse behaviorsmoking cessationdoxazosinmedication effect on smoking lapse behaviormedication effect on smoking cessationstress

Outcome Measures

Primary Outcomes (1)

  • Latency (Min) to Initiate Ad-lib Smoking Session

    Latency to start smoking in the stress and neutral ad-lib smoking lab sessions. Subjects had the opportunity to delay smoking for 50 minutes (delay period). Once the subject decides to smoke, the 1 hour ad-lib smoking session begins. They can chose to smoke as little or as much as they wish.

    0 up to 50 minutes (Delay Period)

Secondary Outcomes (1)

  • Number of Cigarettes Smoked During Ad-lib Session

    60 minutes (ad-lib smoking period)

Study Arms (3)

Doxazosin 4mg/day

EXPERIMENTAL

doxazosin 4mg/day

Drug: Doxazosin 4mg/day

Placebo

PLACEBO COMPARATOR

placebo control

Drug: Placebo

Doxazosin 8mg/day

EXPERIMENTAL

doxazosin 8mg/day

Drug: Doxazosin 8mg/day

Interventions

Doxazosin 4mg/dayDRUG

4 mg/day with 3-week lead-in medication period. Maintained at steady state for duration of the study. 5-day taper at the end of the study.

Also known as: Cardura
Doxazosin 4mg/day
PlaceboDRUG

Placebo

Placebo
Doxazosin 8mg/dayDRUG

8 mg/day with 3-week lead-in medication period. Maintained at steady state for duration of the study. 5-day taper at the end of the study.

Also known as: Cardura
Doxazosin 8mg/day

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Ages 18-60
  • Able to read and write English
  • Smoker
  • Motivated to Quit Smoking

You may not qualify if:

  • Any significant current medical conditions that would contraindicate smoking
  • Current Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) abuse or dependence of other substances, other than nicotine dependence or alcohol abuse
  • Positive test results at intake appointment on urine drug screens for illicit drugs
  • Past 30 day use of psychoactive drugs including anxiolytics and antidepressants
  • Women who are pregnant or nursing
  • Suicidal, homicidal or evidence of current severe mental illness such as schizophrenia, bipolar disorder or major depression, or anxiety disorders
  • Participants who have donated blood within the past 6 weeks
  • Individuals who are currently taking other medications prescribed for smoking cessation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale Center for Clinical Investigations, Yale University

New Haven, Connecticut, 06519, United States

Location

MeSH Terms

Conditions

SmokingSmoking Cessation

Interventions

Doxazosin

Condition Hierarchy (Ancestors)

BehaviorHealth Behavior

Intervention Hierarchy (Ancestors)

PrazosinQuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Results Point of Contact

Title
Sherry McKee, PhD
Organization
Yale School of Medicine
sherry.mckee@yale.edu
203-737-3529

Study Officials

  • Sherry A McKee, PhD

    Yale University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Psychiatry

Study Record Dates

First Submitted

November 9, 2012

First Posted

November 21, 2012

Study Start

February 1, 2013

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

February 20, 2018

Results First Posted

December 20, 2017

Record last verified: 2018-01

Locations

US(1)