Clinical trial NCT01789125: Smoking Termination / Anxiety Reduction Treatment (ST/ART)
Official title: Augmenting Smoking Cessation With Transdiagnostic CBT for Smokers With Anxiety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Smoking
Anxiety Disorders
Keywords: anxiety
stress
smoking
cessation
Lead sponsor: University of Houston
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2013-02-11
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary aim of this research study is to enhance smoking cessation outcome among smokers with anxiety disorders. The investigators are comparing two group treatment approaches: (1) An educational-supportive psychotherapy and standard smoking cessation treatment, and (2) An integrated smoking cessation and anxiety treatment program (START). Both treatments also utilize nicotine replacement therapy.

Detailed description: The chief objective of the proposed study is to develop an integrated standard smoking cessation treatment and transdiagnostic anxiety disorder treatment for smokers with anxiety disorders. The intervention is designed to promote smoking cessation and reduce (a) anxiety symptoms, (b) depression, and (c) the cognitive factor of AS, thereby reducing three notable emotional risk factors of smoking cessation relapse, while at the same time targeting (d) nicotine withdrawal symptoms. The intervention development approach will follow a staged model consistent with NIH guidelines for developing and standardizing behavioral therapies. During the first year, startup activities will include piloting the integrated intervention on a subset of individuals, soliciting internal and external expert consultant and participant feedback, and development of the final treatment protocol. The goal during this phase of the project will be to establish feasibility of treatment delivery, participant acceptability, and potential for an effect. During the following two years, a pilot two-arm efficacy study will be undertaken. The two arms of the randomized trial (RCT) will be: (a) the integrated smoking cessation treatment, consisting of a standard smoking cessation intervention (i.e., CBT-Smoking + Nicotine Replacement Therapy \[NRT\]) plus a transdiagnostic CBT for anxiety (Smoking Termination and Anxiety Reduction Treatment; START) or (b) standard smoking cessation intervention (i.e., CBT-Smoking + NRT) plus contact control (ST+CTRL). The primary outcomes will be short- and long-term point prevalence abstinence (PPA) and time to first smoking lapse and relapse. The following specific aims are proposed: 1. To compare, in a pilot RCT, the effects of START vs. ST+CTRL on smoking cessation outcomes: Short- and longterm PPA. The investigators expect that PPA will be higher, both in the short- and longterm, for those in the START condition compared to those in ST+CTRL. Similarly, The investigators expect the rate of decline in abstinence over time to be slower in START than in ST+CTRL Time to first smoking lapse and time to smoking relapse. The investigators expect mean time to first lapse and to relapse to be greater for those in the START compared to those in the ST+CTRL condition. 2. To compare, in a pilot RCT, the effect of START vs. ST+CTRL on the remission of anxiety disorders, anxiety and depressive symptoms, anxiety sensitivity, and nicotine withdrawal symptoms. 3. To explore the mechanisms by which START improves smoking cessation. The investigators expect that: Treatments over time will directly cause changes in abstinence and withdrawal symptoms, AS, anxiety symptoms, depressed mood (i.e., the proposed mediators of change in abstinence); The effect of treatment on anxiety symptoms and depressed mood will be moderated by treatment condition, such that those receiving START will improve more than those receiving ST+CTRL Changes in each mediator over time will lead to improvements in abstinence over time, and decreases in AS over time will lead to improvements in anxiety symptoms and depressed mood over time.

Eligibility criteria: Inclusion Criteria:

* Ages 18-65 years old
* Capable of providing informed consent
* Willing to attend all study visits and comply with the protocol
* Daily smoker for at least one year
* Currently smoke an average of at least 6 cigarettes per day
* Report a motivation to quit smoking in the next 6 weeks of at least 5 on a 10-point scale

Exclusion Criteria:

* Use of other tobacco products
* Current or past psychotic disorders of any type, or comorbid psychiatric conditions that are relative or absolute contraindications to the use of any treatment option in the study protocol
* Currently suicidal or high suicide risk
* Current use of any pharmacotherapy or psychotherapy for smoking cessation not provided by the researchers during the quit attempt
* Unwilling to cease use of benzodiazepines or other fast-acting anxiolytics
* Concurrent psychotherapy initiated in the past three months, or ongoing anxiety psychotherapy
* Current or intended participation in a concurrent substance abuse treatment
* Insufficient command of English to participate in assessment or treatment

Primary outcomes:
measure: Short- and long-term point prevalence abstinence
timeFrame: Change from baseline at 1, 2, 4, 8, 10, 16, and 24 weeks post quit day.
Secondary outcomes:
measure: Time to first smoking lapse and relapse
timeFrame: Change from baseline at 1, 2, 4, 8, 10, 16, and 24 weeks post quit day.
Other outcomes:
Locations:
city: Houston
country: United States
facility: Anxiety and Health Research Laboratory and Substance Use Treatment Clinic, University of Houston
state: Texas
Study officials:
affiliation: University of Houston
name: Michael J Zvolensky, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: