Behavioral Activation Intervention, Reward Processing, and Youth Smoking Cessation

Phase 3

Completed

• Conditions: Smoking
• Interventions: Drug: Transdermal Nicotine Patch

• Registration Number: NCT01351766
• Lead Sponsor: University of Maryland, College Park

Brief Summary

The primary purpose of this study is to develop a specialized behavioral activation treatment for smoking in youths ages 18-21 with elevated depressive symptoms. In the first phase we utilize focus groups and pilot testing with 15 youths to develop the behavioral activation smoking treatment for youth. In Phase II, we will conduct an open-label trial of the new treatment that will include 8 weeks of transdermal nicotine patch, which will begin at the time of quitting smoking. Participants will be followed over 26 weeks post-quit date. A subset of participants will also undergo an fMRI session to examine reward sensitivity.

Detailed Description

1. 18-21 years of age,

2. a regular smoker for at least 6 months

3. currently smoking an average of at least 5 cigarettes per day

4. want to quit smoking

5. report current elevated depressive symptoms

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2011-05-09
• Study First Submitted QC: 2011-05-10
• Study First Posted: 2011-05-11
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Results First Submitted: 2020-09-10
• Results First Submitted QC: 2020-11-09
• Results First Posted: 2020-12-02
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-16
• Last Update Posted: 2022-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

Inclusion Criteria

• between 18 and 21 years of age
• a regular smoker for at least 6 months
• currently smoking an average of at least 5 cigarettes per day
• want to quit smoking
• report current elevated depressive symptoms

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Exclusion Criteria

• current Axis I disorder
• psychoactive substance dependence (excluding nicotine dependence) within the past 6 months
• current use of psychotropic medication or participation in any form of psychotherapy
• a history of significant medical condition (e.g., cardiovascular , neurological, gastrointestinal), pregnancy and/or breast feeding, or other systemic illness
• limited mental competency [Mini Mental State Examination score < 23] and/or the inability to give informed, voluntary, written consent to participate
• current use of any pharmacotherapy for smoking cessation not provided by the researchers during the quit attempt

Additional Exclusion criteria only for the fMRI portion:

• cerebrovascular disease
• high blood pressure
• diabetes
• use of psychotropic medications in 3 weeks prior to participation in fMRI protocol
• exposure to extreme trauma
• lifetime history of mania, psychosis, or pervasive developmental disorder,
• being ambidextrous or left handed
• any metal implants, heart pacemaker, permanent retainer
• tattoos containing metal dyes
• claustrophobia.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Behavioral Activation for Smoking	Transdermal Nicotine Patch	Eight 60-minute group sessions over an eight-week period. Eight weeks of transdermal nicotine patch, which will begin at the time of quitting smoking and will continue after treatment sessions have ended. Transdermal Nicotine: Participants will use 8 weeks of the nicotine patch at 24 hour doses of 21, 14, and 7 mg respectively depending on participant's initial level of nicotine use. Nicotine patch dose will decrease at 2 or 4 week increments also specific to participant's initial nicotine level.

Primary Outcome Measures

Name	Time	Method
Number of Participants Smoking-Abstinent for 7 Days, 12 Weeks Post Quit Date	12 weeks post quit date	7 days of smoking abstinence confirmed via expired carbon monoxide at 12 weeks

Trial Locations

Locations (1)

University of Maryland, College Park; 🇺🇸 College Park, Maryland, United States