Behavioral Activation Intervention, Reward Processing, and Youth Smoking Cessation

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.

Study Overview

• Status: Completed
• Conditions: Smoking
• Intervention / Treatment: Drug: Transdermal Nicotine Patch

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 Type: Interventional
• Enrollment (Actual): 39
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Maryland
    • College Park, Maryland, United States, 20742
      • University of Maryland, College Park

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 21 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Behavioral Activation for Smoking; 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; 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.; Other Names: Nicoderm CQ

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Maryland, College Park
• Collaborators: National Institute on Drug Abuse (NIDA); National Institutes of Health (NIH)

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: May 9, 2011
• First Submitted That Met QC Criteria: May 10, 2011
• First Posted (Estimate): May 11, 2011

Study Record Updates

• Last Update Posted (Actual): May 18, 2022
• Last Update Submitted That Met QC Criteria: May 16, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Behavioral Activation
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: DA029445; R21DA029445 (U.S. NIH Grant/Contract)