Phase 3
N=39
Behavioral Activation Intervention, Reward Processing, and Youth Smoking Cessation
Smoking
Bottom Line
View on ClinicalTrials.gov: NCT01351766 ↗Enrolled (actual)
39
Serious AEs
0.0%
Results posted
Dec 2020
Primary outcome: Primary: Number of Participants Smoking-Abstinent for 7 Days, 12 Weeks Post Quit Date — 7 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Transdermal Nicotine Patch (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Maryland, College Park
- Primary completion
- May 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Smoking-Abstinent for 7 Days, 12 Weeks Post Quit Date |
7 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01351766). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.