Smoking Termination / Anxiety Reduction Treatment (ST/ART)

NCT01789125 | Completed Phase 1 DMC

• 2 other identifiers: 1R34DA03131301A1R34DA031313
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking; Anxiety Disorders

Keywords

anxiety; stress; smoking; cessation

Outcome Measures

Primary Outcomes (1)

• 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.

  Change from baseline at 1, 2, 4, 8, 10, 16, and 24 weeks post quit day.

Secondary Outcomes (1)

• Time to first smoking lapse and relapse

  Change from baseline at 1, 2, 4, 8, 10, 16, and 24 weeks post quit day.

Study Arms (2)

Smoking Termination and Anxiety Reduction Treatment

ACTIVE COMPARATOR

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

Drug: Nicotine Patch; Behavioral: Smoking Termination and Anxiety Reduction Treatment

Educational-Support Psychotherapy

ACTIVE COMPARATOR

Educational-based psychotherapy and standard smoking cessation treatment program

Drug: Nicotine Patch; Behavioral: Education-Supportive Psychotherapy

Interventions

Nicotine Patch DRUG

Also known as: Patch, NRT

Educational-Support Psychotherapy; Smoking Termination and Anxiety Reduction Treatment

Smoking Termination and Anxiety Reduction Treatment BEHAVIORAL

Integrated smoking cessation and anxiety reduction treatment

Smoking Termination and Anxiety Reduction Treatment

Education-Supportive Psychotherapy BEHAVIORAL

Educational-Support Psychotherapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Houston: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

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

Houston, Texas, 77204, United States

Location

MeSH Terms

Conditions

Smoking; Anxiety Disorders

Interventions

Tobacco Use Cessation Devices; Transdermal Patch

Condition Hierarchy (Ancestors)

Behavior; Mental Disorders

Intervention Hierarchy (Ancestors)

Therapeutics; Equipment and Supplies

Study Officials

• Michael J Zvolensky, Ph.D.

  University of Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Hugh Roy and Lillie Cranz Cullen Distinguished University Professor

Study Record Dates

• First Submitted: February 8, 2013
• First Posted: February 11, 2013
• Study Start: March 1, 2012
• Primary Completion: December 1, 2015
• Study Completion: June 1, 2016
• Last Updated: April 23, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)