A Phase 1 interventional study of Nicotine Patch and Smoking Termination and Anxiety Reduction Treatment in Smoking and Anxiety Disorders, sponsored by University of Houston. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-04-23.
Sponsored by University of Houston · Phase 1, Interventional, and Treatment
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.
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.
4,868 studies on the registry are indexed under Anxiety Disorders; 1,390 are open to participants now.
This study's enrollment of 74 is close to the median of 80 across 4,174 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →University of Houston is the lead sponsor of 101 studies on the registry; 17 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 3 (33%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Cognitive-behavioral treatment program that blends smoking cessation and anxiety reduction treatment strategies
Drug: Nicotine Patch · Behavioral: Smoking Termination and Anxiety Reduction Treatment
Educational-based psychotherapy and standard smoking cessation treatment program
Drug: Nicotine Patch · Behavioral: Education-Supportive Psychotherapy
Also known as: Patch, NRT
Integrated smoking cessation and anxiety reduction treatment
Short- and long-term point prevalence abstinence
The investigators will ask participants various questions about their abstinence. The investigators will measure the length of time between when treatment ends and when/ if they start smoking again. The unit of measure will be length of time in days.
Time frame: Change from baseline at 1, 2, 4, 8, 10, 16, and 24 weeks post quit day.
Time to first smoking lapse and relapse
The investigators will ask participants to record the time (in days) of their first (if any) lapse in smoking and their relapse.
Time frame: Change from baseline at 1, 2, 4, 8, 10, 16, and 24 weeks post quit day.
Plan to share: No — Data will be made available upon request.
This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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