NCT01995123

Behavioral Activation for Smoking Cessation in PTSD

Completed NA Results posted Last updated 15 April 2020

What this trial tests

NA trial testing Behavioral Activation Therapy in Tobacco Dependence in 124 participants. Completed in 29 March 2019.

Timeline

8 September 2014

Primary endpoint
29 March 2019

29 March 2019

Quick facts

Lead sponsor	VA Office of Research and Development
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	124
Start date	8 September 2014
Primary completion	29 March 2019
Estimated completion	29 March 2019
Sites	1 location across United States

Drugs / interventions tested

• Behavioral Activation Therapy
• Health and Smoking Education
• Standard Smoking Cessation Therapy

Conditions studied

• Tobacco Dependence — all drugs for Tobacco Dependence →
• PTSD — all drugs for PTSD →

Sponsor

VA Office of Research and Development — full company profile →

Who can join

18 and older, any sex, with Tobacco Dependence or PTSD. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Participants Who Abstained From Smoking Primary · 26 weeks post target quit date

7-day point prevalence abstinence at weeks 4, 12, 20, and 26 post target quit day

Week 4

Group	Value	95% CI
Behavioral Activation Therapy	23
Health and Smoking Education	21

Week 12

Group	Value	95% CI
Behavioral Activation Therapy	20
Health and Smoking Education	19

Week 20

Group	Value	95% CI
Behavioral Activation Therapy	22
Health and Smoking Education	14

Week 26

Group	Value	95% CI
Behavioral Activation Therapy	12
Health and Smoking Education	8

Time to Smoking Relapse Secondary · 26 weeks post target quit date

Days to first relapse after the target quit date

Group	Value	95% CI
Behavioral Activation Therapy	88.41	± 73.46
Health and Smoking Education	84.34	± 72.29

Clinician Administered PTSD Scale Score Secondary · 4 weeks post target quit date (end of treatment)

PTSD symptoms as assessed via the Clinician-Administered PTSD Scale (CAPS). Minimum score = 0, maximum score = 80. Higher scores indicate greater severity of symptoms.

Group	Value	95% CI
Behavioral Activation Therapy	30.78	± 11.80
Health and Smoking Education	27.33	± 13.29

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse event data were collected for 12 weeks post-target quit date while participants were taking study medication (nicotine patch and nicotine gum or lozenge).. Reporting threshold: 3%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Behavioral Activation Therapy

Serious: 7/63 (11%)

Deaths: 1/63

Health and Smoking Education

Serious: 6/61 (10%)

Deaths: 1/61

Serious adverse events (10 terms)

Reaction	System	Behavioral Activation Ther…	Health and Smoking Education
Hospitalized for suicidal ideation	Psychiatric disorders	—	—
Hospitalized for shortness of breath	Respiratory, thoracic and mediastinal disorders	—	—
Hospitalized for chest pain	Cardiac disorders	—	—
Hospitalized for fall	General disorders	—	—
Hospitalized for lightheadedness	Nervous system disorders	—	—
Hospitalized for TIA	Nervous system disorders	—	—
Hospitalized for wound care	Surgical and medical procedures	—	—
Hospitalized for pneumonia	Respiratory, thoracic and mediastinal disorders	—	—
Hospitalized for back pain	Musculoskeletal and connective tissue disorders	—	—
Death	General disorders	—	—

Other adverse events (11 terms — click to expand)

Reaction	System	Behavioral Activation Ther…	Health and Smoking Education
Itching	Skin and subcutaneous tissue disorders	—	—
Vivid dreams	Psychiatric disorders	—	—
Headache	Nervous system disorders	—	—
Persistent indigestion	Gastrointestinal disorders	—	—
Skin rash	Skin and subcutaneous tissue disorders	—	—
Insomnia	Psychiatric disorders	—	—
Nausea	Gastrointestinal disorders	—	—
Dizziness	Nervous system disorders	—	—
Swelling or tingling of the mouth	Skin and subcutaneous tissue disorders	—	—
Hiccups	Gastrointestinal disorders	—	—
Mouth problems	Skin and subcutaneous tissue disorders	—	—

Most-reported serious reactions: Hospitalized for suicidal ideation, Hospitalized for shortness of breath, Hospitalized for chest pain, Hospitalized for fall, Hospitalized for lightheadedness, Hospitalized for TIA, Hospitalized for wound care, Hospitalized for pneumonia.

Data from ClinicalTrials.gov NCT01995123 adverse events section.

Sponsor's own 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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Behavioral Activation for Smoking Cessation in Veterans with Posttraumatic Stress Disorder: A Randomized Clinical Trial.
   Kaye JT, Betts JM, Brubaker E, Webster K, et al · · 2025 · PMID 40071390 · DOI 10.1093/ntr/ntaf054