SmokingPhase 3NCT01351766
Behavioral Activation Intervention, Reward Processing, and Youth Smoking Cessation
A Phase 3 study testing Transdermal Nicotine Patch in people with Smoking, run by University of Maryland, College Park at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 21 years
- Conditions the study is for
- Smoking
- What is being tested?
- Transdermal Nicotine Patch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to May 2013
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 21 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland, College Park
College Park, Maryland, 20742
About this study
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.
Read the detailed description
- 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
- Conditions
- Smoking
- Being tested
- Transdermal Nicotine Patch
- Keywords
- Behavioral Activation
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transdermal Nicotine PatchDrug
Also called Nicoderm CQ
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Transdermal Nicotine Patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 weeks post quit date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2011 (estimated)
- Study startApr 2010
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SmokingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, College Park
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Laura MacPherson, University of Maryland, College Park
- Investigators
- Laura MacPherson, PhD, Principal investigator, University of Maryland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01351766
- Sponsor's protocol ID
- DA029445
- Other IDs
- R21DA029445
- Status last verified
- May 2022
- First submitted
- 9 May 2011
- Last updated
- 18 May 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Activation Intervention, Reward Processing, and Youth Smoking Cessation
- ClinicalTrials.gov ID
- NCT01351766
- Acronym / sponsor ID
- DA029445
- Conditions
- Smoking
- Keywords
- Behavioral Activation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University of Maryland, College ParkUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA)
- Study start
- Apr 2010
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 11 May 2011 (estimated)
- Results
- Posted 2 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Behavioral Activation for Smoking | Experimental | Drug: Transdermal Nicotine PatchEight 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. |
Who may qualify
- Ages
- 18 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transdermal Nicotine PatchAlso: Nicoderm CQTransdermal 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 | Behavioral Activation for Smoking |
Primary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura MacPherson, PhD principal investigator
University of Maryland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Transdermal Nicotine Patch in people with Smoking, run by University of Maryland, College Park at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Smoking-Abstinent for 7 Days, 12 Weeks Post Quit Date (time frame: 12 weeks post quit date). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2022.