Smoking Termination / Anxiety Reduction Treatment (ST/ART) (START)

University of Houston

Status and phase: Completed; Phase 1

Conditions: Anxiety Disorders; Smoking

Treatments: Drug: Nicotine Patch; Behavioral: Smoking Termination and Anxiety Reduction Treatment; Behavioral: Education-Supportive Psychotherapy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01789125

R34DA031313 (U.S. NIH Grant/Contract)

1R34DA03131301A1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 74 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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74 participants in 2 patient groups

Smoking Termination and Anxiety Reduction Treatment

Active Comparator group

Description:

Cognitive-behavioral treatment program that blends smoking cessation and anxiety reduction treatment strategies

Treatment:

Behavioral: Smoking Termination and Anxiety Reduction Treatment

Drug: Nicotine Patch

Educational-Support Psychotherapy

Active Comparator group

Description:

Educational-based psychotherapy and standard smoking cessation treatment program

Treatment:

Behavioral: Education-Supportive Psychotherapy

Drug: Nicotine Patch