Behavioral Activation Intervention, Reward Processing, and Youth Smoking Cessation

NCT01351766 | Completed Phase 3 Results

• 2 other identifiers: DA029445R21DA029445
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking

Keywords

Behavioral Activation

Outcome Measures

Primary Outcomes (1)

• Number of Participants Smoking-Abstinent for 7 Days, 12 Weeks Post Quit Date

  7 days of smoking abstinence confirmed via expired carbon monoxide at 12 weeks

  12 weeks post quit date

Study Arms (1)

Behavioral Activation for Smoking

EXPERIMENTAL

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.

Drug: Transdermal Nicotine Patch

Interventions

Transdermal Nicotine Patch DRUG

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.

Also known as: Nicoderm CQ

Behavioral Activation for Smoking

Eligibility Criteria

• Age: 18 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of Maryland, College Park: lead
• National Institutes of Health (NIH): collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

University of Maryland, College Park

College Park, Maryland, 20742, United States

Location

MeSH Terms

Conditions

Smoking

Interventions

Tobacco Use Cessation Devices; Nicotine

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Laura MacPherson
• Organization: University of Maryland

lauramac.phd@gmail.com

6198578425

Study Officials

• Laura MacPherson, PhD

  University of Maryland

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Principal Investigator

Study Record Dates

• First Submitted: May 9, 2011
• First Posted: May 11, 2011
• Study Start: April 1, 2010
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: May 18, 2022
• Results First Posted: December 2, 2020

Record last verified: 2022-05

Locations

US (1)