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

Primary Purpose

Smoking, Anxiety Disorders

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Nicotine Patch
Smoking Termination and Anxiety Reduction Treatment
Education-Supportive Psychotherapy
Sponsored by
University of Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Smoking focused on measuring anxiety, stress, smoking, cessation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Anxiety and Health Research Laboratory and Substance Use Treatment Clinic, University of Houston

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Smoking Termination and Anxiety Reduction Treatment

Educational-Support Psychotherapy

Arm Description

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

Educational-based psychotherapy and standard smoking cessation treatment program

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
February 8, 2013
Last Updated
April 19, 2019
Sponsor
University of Houston
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT01789125
Brief Title
Smoking Termination / Anxiety Reduction Treatment (ST/ART)
Acronym
START
Official Title
Augmenting Smoking Cessation With Transdiagnostic CBT for Smokers With Anxiety
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Houston
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smoking, Anxiety Disorders
Keywords
anxiety, stress, smoking, cessation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
74 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Smoking Termination and Anxiety Reduction Treatment
Arm Type
Active Comparator
Arm Description
Cognitive-behavioral treatment program that blends smoking cessation and anxiety reduction treatment strategies
Arm Title
Educational-Support Psychotherapy
Arm Type
Active Comparator
Arm Description
Educational-based psychotherapy and standard smoking cessation treatment program
Intervention Type
Drug
Intervention Name(s)
Nicotine Patch
Other Intervention Name(s)
Patch, NRT
Intervention Type
Behavioral
Intervention Name(s)
Smoking Termination and Anxiety Reduction Treatment
Intervention Description
Integrated smoking cessation and anxiety reduction treatment
Intervention Type
Behavioral
Intervention Name(s)
Education-Supportive Psychotherapy
Primary Outcome Measure Information:
Title
Short- and long-term point prevalence abstinence
Description
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.
Secondary Outcome Measure Information:
Title
Time to first smoking lapse and relapse
Description
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael J Zvolensky, Ph.D.
Organizational Affiliation
University of Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
Anxiety and Health Research Laboratory and Substance Use Treatment Clinic, University of Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77204
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Data will be made available upon request.
Links:
URL
http://uh.edu/ahrl-sutc
Description
Project Website

Learn more about this trial

Smoking Termination / Anxiety Reduction Treatment (ST/ART)

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