Behavioral Activation for Smoking Cessation in PTSD

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01995123
• Date of registration: 20/11/2013
• Prospective Registration: Yes
• Primary sponsor: VA Office of Research and Development
• Public title: Behavioral Activation for Smoking Cessation in PTSD
• Scientific title: Behavioral Activation for Smoking Cessation in Veterans With PTSD
• Date of first enrolment: September 8, 2014
• Target sample size: 124
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01995123
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Investigator, Outcomes Assessor).
• Phase: N/A

Countries of recruitment

United States

Contacts

• Name: Jessica M Cook, PhD
• Affiliation: William S. Middleton Memorial Veterans Hospital, Madison, WI

Key inclusion & exclusion criteria

Inclusion Criteria:

- Report smoking an average of 10 or more cigarettes daily for at least six months

- Report a desire to quit smoking

- Meet criteria for current PTSD

- Speak and read English

- Agree to participate in the study

- Be 18 years old

- Be a veteran

Exclusion Criteria:

- Meeting criteria for psychotic or bipolar disorder

- Psychoactive substance abuse or dependence (excluding nicotine dependence) within the
past 6 months

- Inability to give informed, voluntary, written consent to participate

- Current use of any pharmacotherapy for smoking cessation not provided by the
researchers during the quit attempt

- Use of non-cigarette tobacco products as a primary form of tobacco use

- Being currently suicidal or homicidal

- Being medically unable to use the nicotine patch or nicotine gum/lozenge

- Psychotropic medication changes within 3 months of study initiation and during active
treatment

- Current engagement in evidence-based therapies for PTSD or depression

- Pregnant or trying to become pregnant

- Incarceration



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Tobacco Dependence

PTSD

Intervention(s)

Behavioral: Health and Smoking Education

Behavioral: Behavioral Activation Therapy

Behavioral: Standard Smoking Cessation Therapy

Primary Outcome(s)

Percentage of Participants Who Abstained From Smoking [Time Frame: 26 weeks post target quit date]

Secondary Outcome(s)

Clinician Administered PTSD Scale Score [Time Frame: 4 weeks post target quit date (end of treatment)]

Time to Smoking Relapse [Time Frame: 26 weeks post target quit date]

Secondary ID(s)

MHBA-002-12F

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University of Wisconsin, Madison

Results

• Results available: Yes
• Date Posted: 15/04/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01995123