Coping Skills Treatment for Smoking Cessation

NCT01061528 | Completed Results DMC

• 2 other identifiers: PHI0906-002R01DA017332
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

Brief Summary

The primary purpose of this study is to evaluate the efficacy of a new type of exposure- and acceptance-based smoking cessation treatment vs. standard behavioral smoking cessation treatment, in conjunction with the use of the transdermal nicotine patch. In both treatments, participants will receive one 60-minute individual session, seven 2-hour group sessions and two individual brief telephone contacts over an eight-week period. Both treatments include 8 weeks of transdermal nicotine patch, which will begin at the time of quitting smoking and will continue after the treatment sessions have ended. Participants will provide follow-up data with regard to their smoking status through a one-year follow-up period.

Conditions

Nicotine Dependence

Keywords

cigarette smoking; smoking cessation; nicotine dependence

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Biochemically Verified Smoking Abstinence

  1. Carbon monoxide of expired air 2. Salivary cotinine level of saliva

  Six months

Study Arms (2)

New Smoking Cessation Counseling

EXPERIMENTAL

* One 60-minute individual session * Seven 2-hour group sessions * Two individual brief telephone contacts over an eight-week period. * Eight weeks of transdermal nicotine patch, which will begin at the time of quitting smoking and will continue even after the treatment sessions have ended. Standard nicotine patch dosing will be used.

Drug: Transdermal Nicotine

Standard Smoking Cessation Counseling

ACTIVE COMPARATOR

* One 60-minute individual session * Seven 2-hour group sessions * Two individual brief telephone contacts over an eight-week period. * Eight weeks of transdermal nicotine patch, which will begin at the time of quitting smoking and will continue even after the treatment sessions have ended. Standard nicotine patch dosing will be used.

Drug: Transdermal Nicotine

Interventions

Transdermal Nicotine DRUG

Participants will use the full strength 21mg. patch for 4 weeks, will taper to the 14 mg. patch for the next 2 weeks, and then to the 7 mg. patch for the remaining 2 weeks of treatment.

Also known as: Nicoderm CQ

New Smoking Cessation Counseling; Standard Smoking Cessation Counseling

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old
• regular smoker for at least one year
• currently smoking 10 or more cigarettes per day

You may not qualify if:

• Current Axis I disorder
• Psychoactive substance abuse or dependence (excluding nicotine dependence) within past year
• Current suicidal risk
• Pregnancy or breast feeding
• Use of nicotine replacement products or bupropion

Sponsors & Collaborators

• Butler Hospital: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Butler Hospital

Providence, Rhode Island, 02906, United States

Location

MeSH Terms

Conditions

Tobacco Use Disorder; Cigarette Smoking; Smoking Cessation

Interventions

Tobacco Use Cessation Devices; Nicotine

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Tobacco Smoking; Smoking; Behavior; Tobacco Use; Health Behavior

Intervention Hierarchy (Ancestors)

Therapeutics; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Dr. Richard A. Brown
• Organization: University of Texas at Austin

brown2@utexas.edu

512-471-8584

Study Officials

• Richard A Brown, PhD

  Butler Hospital/Brown Medical School

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2010
• First Posted: February 3, 2010
• Study Start: September 1, 2009
• Primary Completion: August 1, 2013
• Study Completion: October 1, 2013
• Last Updated: October 16, 2018
• Results First Posted: June 15, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)