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

Smoking research study

What is the primary objective of this study?

The primary aim of this research study is to enhance smoking cessation outcome among smokers with anxiety disorders. We 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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Smoking

Anxiety Disorders

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Nicotine Patch

Behavioral:Smoking Termination and Anxiety Reduction TreatmentIntegrated smoking cessation and anxiety reduction treatment

Behavioral:Education-Supportive Psychotherapy

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Smoking Termination and Anxiety Reduction TreatmentCognitive-behavioral treatment program that blends smoking cessation and anxiety reduction treatment strategies

Educational-Support PsychotherapyEducational-based psychotherapy and standard smoking cessation treatment program

Study Status

Completed

Start Date: March 2012

Completed Date: June 2016

Phase: Phase 1

Type: Interventional

Design:

Primary Outcome: Smoking status

Secondary Outcome:

Study sponsors, principal investigator, and references

Principal Investigator: Michael J Zvolensky, Ph.D.

Lead Sponsor: University of Houston

Collaborator: National Institute on Drug Abuse (NIDA)

More information:https://clinicaltrials.gov/show/NCT01789125

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