Behavioral Activation for Smoking Cessation in Veterans With PTSD

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified December 2013 by University of Wisconsin, Madison
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT01947725
First received: September 10, 2013
Last updated: December 27, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Posttraumatic Stress Disorders
PTSD
Smoking Cessation
Smoking
Drug: Nicotine patch
Drug: Nicotine gum or nicotine lozenge
Behavioral: Standard Smoking Cessation Therapy
Behavioral: Health and Smoking Education
Behavioral: Behavioral Activation Treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Behavioral Activation for Smoking Cessation in Veterans With PTSD

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • Abstinence from tobacco [ Time Frame: 26 weeks post target quit date ] [ Designated as safety issue: No ]
    7-day point prevalence abstinence at 26 weeks post-quit (measured via single end-point analysis and via abstinence over time).


Secondary Outcome Measures:
  • Time to tobacco relapse [ Time Frame: 26 weeks post target quit date ] [ Designated as safety issue: No ]
    Time to first relapse after target quit date.

  • PTSD symptoms [ Time Frame: 5 weeks post target quit date (end of treatment) ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 120
Study Start Date: January 2014
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: September 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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. In addition, this arm will receive standard smoking cessation therapy, nicotine patch, and either nicotine gum or nicotine lozenge.
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.
Other Name: Nicoderm
Drug: 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.
Other Name: Nicorette
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.
Behavioral: 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.
Experimental: 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. In addition, this arm will receive standard smoking cessation therapy, nicotine patch, and either nicotine gum or nicotine lozenge.
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.
Other Name: Nicoderm
Drug: 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.
Other Name: Nicorette
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.
Behavioral: 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.

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01947725

Locations
United States, Wisconsin
William S. Middleton Memorial Veterans Hospital Not yet recruiting
Madison, Wisconsin, United States, 53705
Contact: Kirsten L Webster, BA    608-256-1901 ext 17854    klwebster@medicine.wisc.edu   
Principal Investigator: Jessica M Cook, PhD         
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: Jessica M Cook, PhD William S. Middleton Memorial Veterans Hospital, University of Wisconsin-Madison
  More Information

No publications provided

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01947725     History of Changes
Other Study ID Numbers: 2013-0757
Study First Received: September 10, 2013
Last Updated: December 27, 2013
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by University of Wisconsin, Madison:
Posttraumatic Stress Disorders
PTSD
Smoking Cessation
Smoking
Behavior Therapy

Additional relevant MeSH terms:
Smoking
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Habits
Anxiety Disorders
Mental Disorders
Nicotine
Nicotine polacrilex
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 26, 2014