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.

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Key information

Conditions

Smoking Behavior

Age range

18 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Maryland, College Park

College Park, Maryland, 20742, United States

About this study

18-21 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Nicoderm CQ

Primary outcomes

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

Time frame: 12 weeks post quit date

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

Sponsors and collaborators

Lead sponsor

University of Maryland, College Park

Other

Collaborators

National Institute on Drug Abuse (NIDA)
National Institutes of Health (NIH)

Registry information

Important dates

Study start: 2010
Primary completion: 2013
Study completion: 2013
First posted: May 11, 2011
Registry last updated: May 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed