Smoking Cessation for Depression and Anxiety Treatment

NCT ID: NCT02002858

Last Updated: 2017-07-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2017-05-31

Brief Summary

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The primary aim of this research study is to enhance smoking cessation outcome among smokers with elevated anxiety and depression. 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 and depression management treatment program (SDAT). Both treatments also utilize nicotine replacement therapy.

Detailed Description

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Conditions

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Smoking Anxiety Disorders Depression Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Depression and Anxiety Smoking Cessation Treatment

Cognitive-behavioral treatment program that blends smoking cessation, anxiety, and depression management/reduction treatment strategies

Group Type EXPERIMENTAL

Nicotine Patch

Intervention Type DRUG

Depression and Anxiety Smoking Cessation Treatment

Intervention Type BEHAVIORAL

Cognitive-behavioral treatment program that blends smoking cessation, anxiety, and depression management/reduction treatment strategies

Educational-Support Psychotherapy

Educational-based psychotherapy and standard smoking cessation treatment program

Group Type ACTIVE_COMPARATOR

Nicotine Patch

Intervention Type DRUG

Educational-Support Psychotherapy

Intervention Type BEHAVIORAL

Educational-based psychotherapy and standard smoking cessation treatment program

Interventions

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Nicotine Patch

Intervention Type DRUG

Depression and Anxiety Smoking Cessation Treatment

Cognitive-behavioral treatment program that blends smoking cessation, anxiety, and depression management/reduction treatment strategies

Intervention Type BEHAVIORAL

Educational-Support Psychotherapy

Educational-based psychotherapy and standard smoking cessation treatment program

Intervention Type BEHAVIORAL

Other Intervention Names

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SDAT

Eligibility Criteria

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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
* Elevated anxiety or depression

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
* Concurrent psychotherapy initiated within three months of baseline, or ongoing psychotherapy of any duration directed specifically toward the treatment of anxiety or depression
* Current or intended participation in a concurrent substance abuse treatment
* Current non-nicotine substance dependence
* Insufficient command of English to participate in assessment or treatment
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

University of Houston

OTHER

Sponsor Role lead

Responsible Party

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Michael J. Zvolensky, Ph.D.

Hugh Roy and Lillie Cranz Cullen Distinguished University Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael J Zvolensky, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Houston

Locations

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Anxiety and Health Research Laboratory and Substance Use Treatment Clinic

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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R34DA034741

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1R34DA03474101

Identifier Type: -

Identifier Source: org_study_id

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