Behavioral Activation for Smoking Cessation in Veterans With PTSD

Smoking Cessation Clinical Trial

Official title:

Behavioral Activation for Smoking Cessation in Veterans With PTSD

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01947725
• Other study ID #: 2013-0757
• Status: Recruiting
• Phase: N/A
• First received: September 10, 2013
• Last updated: March 30, 2017
• Start date: January 2014
• Est. completion date: September 2018

Study information

• Verified date: March 2017
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to examine whether behavioral activation as an adjuvant to standard smoking cessation treatment improves smoking cessation outcomes among veterans with PTSD relative to a comparably intense combination of standard smoking cessation treatment + health and smoking education. It is expected that behavioral activation will produce more successful results than health and smoking education when paired with standard smoking cessation treatment.

Description:

The purpose of this study is to examine whether behavioral activation as an adjuvant to standard smoking cessation treatment improves smoking cessation outcomes among veterans with PTSD relative to a comparably intense combination of standard smoking cessation treatment + health and smoking education. It is expected that behavioral activation will produce more successful results than health and smoking education when paired with standard smoking cessation treatment.

After an initial phone screen, in-person screening, and baseline assessment, enrolled participants will be randomized to either behavioral activation therapy and standard smoking cessation treatment (BA+ST) or health and smoking education and standard smoking cessation treatment (HSE+ST). Both groups will meet with a therapist once a week for 8 weeks to receive either BA+ST or HSE+ST. Participants' mood and smoking outcomes will be monitored throughout the 8 weeks of treatment and at 2 follow-up visits and 2 follow-up phone calls.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: September 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Posttraumatic Stress Disorders
• PTSD
• Smoking
• Smoking Cessation
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Drug:
• Nicotine patch
Subjects in all arms will receive 12 weeks of nicotine patch. The dosage will be 4 weeks of 21 mg, 4 weeks of 14 mg, and 4 weeks of 7 mg patches as is approved by the FDA and is standard treatment at the study facility. This dosage may be adjusted based on the needs of the subject as is the standard of care.
• Nicotine gum or nicotine lozenge
Subjects in all arms will receive either nicotine gum or nicotine lozenge (depending on their preference). Participants who smoke less than 25 cigarettes/day will receive 2-mg gum/lozenge; participants smoking 25 or more cigarettes/day will receive 4-mg gum/lozenge. Participants will be told to try to use one piece of gum every 1-2 hours. However, participants will also be told that they may not be able to take a full, recommended dose of oral Nicotine Replacement Therapy (NRT) given their conjoint use of the patch. Participants will be urged to use at least 5 pieces/day, unless this amount of use produces negative (toxic) effects.

Behavioral:
• Standard Smoking Cessation Therapy
Subject in both arms will receive a standard, individual smoking cessation treatment. Treatment will be delivered in eight, 20-minute individual sessions over an 8-week period.
• Health and Smoking Education
Health and Smoking Education (HSE) Treatment will be delivered in eight, 30 minute individual sessions over an 8-week period. HSE treatment will focus on smoking, health, and the impact of smoking on the subject's health.
• Behavioral Activation Treatment
Behavioral Activation (BA) Treatment will be delivered in eight, 30 minute individual sessions over an 8-week period. BA treatment will focus on encouraging subjects to participate in activities that they find enjoyable and rewarding.

Locations

Country	Name	City	State
United States	William S. Middleton Memorial Veterans Hospital	Madison	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Abstinence from tobacco	7-day point prevalence abstinence at 26 weeks post-quit (measured via single end-point analysis and via abstinence over time).	26 weeks post target quit date
Secondary	Time to tobacco relapse	Time to first relapse after target quit date.	26 weeks post target quit date
Secondary	PTSD symptoms	PTSD symptoms [as assessed with Clinician-Administered PTSD Scale (CAPS) interview that involves a clinician asking participants to rate PTSD symptoms on Likert Scales] 5 weeks following target quit date.	5 weeks post target quit date (end of treatment)