Cigarette SmokerNCT02697227
Behavioral Activation Therapy and Nicotine Replacement Therapy in Increasing Smoking Cessation
A study testing Behavioral Intervention, Laboratory Biomarker Analysis and Nicotine Patch in people with Cigarette Smoker and Tobacco Use Disorder, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This randomized clinical trial studies how well behavioral activation therapy and nicotine replacement therapy work in increasing smoking cessation. Behavioral interventions use techniques to help patients change the way they react to environmental triggers that may cause a negative reaction. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Cigarette Smoker, Tobacco Use Disorder
- What is being tested?
- Behavioral Intervention, Laboratory Biomarker Analysis and Nicotine Patch
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Aug 2016to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Smoking 5 or more cigarettes, little cigars or cigarillos per day, on average, within the 2 months preceding the screening visit and expired carbon monoxide (CO) greater than or equal to 6 parts per million (ppm); (if < 6, then NicAlert Strip > 2)
- Interested in treatment that might change smoking behavior
- Able to follow verbal and written instructions in English and complete all aspects of the study
- Provide informed consent and agree to all assessments and study procedures
- Have an address and telephone number where they may be reached
- Be the only participant in their household
Who cannot join
- Within the month immediately preceding the screening visit, use of any form of tobacco products other than cigarettes, little cigars or cigarillos on 3 or more days within a week if the individual refuses to refrain from such tobacco use during the course of the study
- Current enrollment or plans to enroll in another smoking cessation program in the next 6 months
- Plan to use other nicotine substitutes (i.e., over-the-counter [OTC] or prescription medication for smoking cessation) or smoking cessation treatments in the next 6 months
- Uncontrolled hypertension (systolic blood pressure [SBP] greater than 180 or diastolic blood pressure [DBP] greater than 110)
- Reports diagnosis of seizure disorder or a history of neurological illness or closed head injury that in the opinion of the principal investigator (PI) or designated expert(s) feels that it would affect the results of the electroencephalogram (EEG)
- Current use of certain medications:
Show all 22Show fewer
- Smoking cessation meds (last 7 days), i.e., Wellbutrin, bupropion, Zyban, NRT, Chantix
- Certain medications to treat depression (last 14 days), i.e. monoamine oxidase inhibitors (MAOIs) and Elavil (amitriptyline), or
- Other medications listed on the exclusionary medications list
- Meet criteria for the following psychiatric and/or substance use disorders as assessed by the Mini International Neuropsychiatric Interview (MINI): items C (current manic or hypomanic episode only), I (alcohol abuse - alcohol addendum-past 6 months only; current alcohol dependence), J (substance abuse - substance abuse addendum - past 6 months only; current substance dependence), K (psychotic disorder or mood disorder with psychotic features); individuals who meet criteria for non-exclusionary psychiatric disorders that are considered clinically unstable and/or unsuitable to participate as determined by the principal investigator
- Individuals rated as moderate (9-16) to high (17 or greater) on suicidality as assessed by module B of the MINI
- Psychiatric hospitalization within 1 year of screening date
- A positive urine pregnancy test during the screening period; women who are two years post-menopausal, or who have had a tubal ligation or a partial or full hysterectomy will not be subject to a urine pregnancy test
- Pregnant, breast-feeding or of childbearing potential and is not protected by a medically acceptable, effective method of birth control while enrolled in the study; medically acceptable contraceptives include: (1) approved hormonal contraceptives (such as birth control pills, patches, implants or injections), (2) barrier methods (such as a condom or diaphragm) used with a spermicide, or (3) an intrauterine device (IUD); contraceptive measures sold for emergency use after unprotected sex are not acceptable methods for routine use
- History of hypersensitivity or allergic reaction to NRT, or any component of its formulation
- Any medical or psychiatric condition, illness, disorder, or concomitant medication that could compromise participant safety or treatment, as determined by the principal investigator
- Subject considered by the investigator as unsuitable candidate for receipt of NRT, or unstable to be followed up throughout the entire duration of the study
- Must not have visual problems that in the investigators opinion would interfere in the completion of the study assessments
- Unwilling to change hairstyle or remove a wig as necessary for the appointment to accommodate the net that is required to be worn on the scalp during the study procedure
- Positive toxicology screen for any of the following drugs: cocaine, opiates, methadone, benzodiazepines, barbiturates, amphetamines, methamphetamines, or phencyclidine (PCP)
- Participants with valid prescriptions for opiates, benzodiazepines, barbiturates, amphetamines or methadone will not be excluded
- Participants failing the toxicology screen will be allowed to re-screen once; if they test positive again, they will not be allowed to return for 90 days
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Low Reward Sensitivity and Behavioral Activation Therapy for Smoking Cessation
This randomized clinical trial studies how well behavioral activation therapy and nicotine replacement therapy work in increasing smoking cessation. Behavioral interventions use techniques to help patients change the way they react to environmental triggers that may cause a negative reaction. Giving behavioral activation therapy and nicotine replacement therapy may help patients quit smoking or change their smoking behavior.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine the comparative effectiveness of Behavioral Activation Treatment for Smoking (BATS) plus nicotine replacement therapy (NRT) versus standard cessation treatment plus NRT on high reward sensitivity smokers (IRS+) and low reward sensitivity (IRS-) smokers.
II. To identify mediators of the BATS plus NRT treatment effect in IRS- smokers.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I (STANDARD CESSATION): Patients receive NRT patch daily for 8 weeks. Patients receive individual behavioral treatment sessions consisting of behavioral treatment strategies for smoking cessation and health education information over 45 minutes for 8 sessions.
GROUP II (BATS): Patients receive NRT patch daily for 8 weeks. Patients receive individual treatment sessions consisting of standard cessation (SC) strategies and behavioral activation (BA) strategies over 45 minutes for 8 sessions.
After completion of study intervention, patients are followed up at 3 months.
- Conditions
- Cigarette Smoker, Tobacco Use Disorder
- Being tested
- Behavioral Intervention, Laboratory Biomarker Analysis, Nicotine Patch, Questionnaire Administration, Smoking Cessation Intervention
- Medical subject headings
- Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral InterventionBehavioural
Also called Behavior Conditioning Therapy, behavior modification, Behavior or Life Style Modifications, Behavior Therapy
Receive BATS counseling
Laboratory Biomarker AnalysisOther
Correlative studies
Nicotine PatchDrug
Also called NicoDerm CQ, Nicotine Skin Patch, Nicotine Transdermal Patch
Receive nicotine patch
Questionnaire AdministrationOther
Ancillary studies
Smoking Cessation InterventionBehavioural
Also called Smoking and Tobacco Use Cessation Interventions
Receive standard smoking cessation counseling
| Study group | Role | What they receive |
|---|---|---|
| Group I (NRT, SC) | Active comparator | Patients receive NRT patch daily for 8 weeks. Patients receive individual behavioral treatment sessions consisting of behavioral treatment strategies for smoking cessation and health education information over 45 minutes for 8 sessions. Receives: Other: Laboratory Biomarker Analysis; Drug: Nicotine Patch; Other: Questionnaire Administration; Behavioral: Smoking Cessation Intervention |
| Group II (NRT, BATS) | Active comparator | Patients receive NRT patch daily for 8 weeks. Patients complete individual treatment sessions consisting of SC strategies and BA strategies over 45 minutes for 8 sessions. Receives: Behavioral: Behavioral Intervention; Other: Laboratory Biomarker Analysis; Drug: Nicotine Patch; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of behavioral activation treatment for smoking plus nicotine replacement therapy versus standard cessation treatment plus nicotine replacement therapy defined as abstinence rate in low reward sensitivity- and + smokers
Measured: Up to 4 months
Mediators of the behavioral activation treatment for smoking plus nicotine replacement therapy treatment effect in low reward sensitivity- smokers
The primary outcome measure is cigarettes per day (CPD) as measured by Time Line Follow Back. This self-report will be biochemically verified by either carbon monoxide breath sample or nicotine sample
Measured: Up to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2016 (estimated)
- Study start5 Aug 2016
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cigarette SmokerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Jennifer A Minnix, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02697227
- Sponsor's protocol ID
- 2015-0879
- Other IDs
- NCI-2016-00674, 2015-0879, R34DA037391
- Status last verified
- Jun 2026
- First submitted
- 24 Feb 2016
- Last updated
- 11 Jun 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Reward Sensitivity and Behavioral Activation Therapy for Smoking Cessation
- ClinicalTrials.gov ID
- NCT02697227
- Acronym / sponsor ID
- 2015-0879
- Conditions
- Cigarette Smoker, Tobacco Use Disorder
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 85 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 5 Aug 2016 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 3 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized clinical trial studies how well behavioral activation therapy and nicotine replacement therapy work in increasing smoking cessation. Behavioral interventions use techniques to help patients change the way they react to environmental triggers that may cause a negative reaction. Giving behavioral activation therapy and nicotine replacement therapy may help patients quit smoking or change their smoking behavior.
Detailed description
PRIMARY OBJECTIVES:
- To determine the comparative effectiveness of Behavioral Activation Treatment for Smoking (BATS) plus nicotine replacement therapy (NRT) versus standard cessation treatment plus NRT on high reward sensitivity smokers (IRS+) and low reward sensitivity (IRS-) smokers.
II. To identify mediators of the BATS plus NRT treatment effect in IRS- smokers.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I (STANDARD CESSATION): Patients receive NRT patch daily for 8 weeks. Patients receive individual behavioral treatment sessions consisting of behavioral treatment strategies for smoking cessation and health education information over 45 minutes for 8 sessions.
GROUP II (BATS): Patients receive NRT patch daily for 8 weeks. Patients receive individual treatment sessions consisting of standard cessation (SC) strategies and behavioral activation (BA) strategies over 45 minutes for 8 sessions.
After completion of study intervention, patients are followed up at 3 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (NRT, SC) | Active comparator | Other: Laboratory Biomarker Analysis, Drug: Nicotine Patch, Other: Questionnaire Administration, Behavioral: Smoking Cessation InterventionPatients receive NRT patch daily for 8 weeks. Patients receive individual behavioral treatment sessions consisting of behavioral treatment strategies for smoking cessation and health education information over 45 minutes for 8 sessions. |
| Group II (NRT, BATS) | Active comparator | Behavioral: Behavioral Intervention, Other: Laboratory Biomarker Analysis, Drug: Nicotine Patch, Other: Questionnaire AdministrationPatients receive NRT patch daily for 8 weeks. Patients complete individual treatment sessions consisting of SC strategies and BA strategies over 45 minutes for 8 sessions. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Smoking 5 or more cigarettes, little cigars or cigarillos per day, on average, within the 2 months preceding the screening visit and expired carbon monoxide (CO) greater than or equal to 6 parts per million (ppm); (if < 6, then NicAlert Strip > 2)
- Interested in treatment that might change smoking behavior
- Able to follow verbal and written instructions in English and complete all aspects of the study
- Provide informed consent and agree to all assessments and study procedures
- Have an address and telephone number where they may be reached
Key exclusion criteria (22 listed)
- Within the month immediately preceding the screening visit, use of any form of tobacco products other than cigarettes, little cigars or cigarillos on 3 or more days within a week if the individual refuses to refrain from such tobacco use during the course of the study
- Current enrollment or plans to enroll in another smoking cessation program in the next 6 months
- Plan to use other nicotine substitutes (i.e., over-the-counter [OTC] or prescription medication for smoking cessation) or smoking cessation treatments in the next 6 months
- Uncontrolled hypertension (systolic blood pressure [SBP] greater than 180 or diastolic blood pressure [DBP] greater than 110)
- Reports diagnosis of seizure disorder or a history of neurological illness or closed head injury that in the opinion of the principal investigator (PI) or designated expert(s) feels that it would affect the results of the electroencephalogram (EEG)
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 |
|---|---|---|
| Behavioral InterventionAlso: Behavior Conditioning Therapy, behavior modification, Behavior or Life Style Modifications, Behavior TherapyReceive BATS counseling | Behavioural | Group II (NRT, BATS) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Group I (NRT, SC), Group II (NRT, BATS) |
| Nicotine PatchAlso: NicoDerm CQ, Nicotine Skin Patch, Nicotine Transdermal PatchReceive nicotine patch | Drug | Group I (NRT, SC), Group II (NRT, BATS) |
| Questionnaire AdministrationAncillary studies | Other | Group I (NRT, SC), Group II (NRT, BATS) |
| Smoking Cessation InterventionAlso: Smoking and Tobacco Use Cessation InterventionsReceive standard smoking cessation counseling | Behavioural | Group I (NRT, SC) |
Primary outcome
Effectiveness of behavioral activation treatment for smoking plus nicotine replacement therapy versus standard cessation treatment plus nicotine replacement therapy defined as abstinence rate in low reward sensitivity- and + smokers
Time frame: Up to 4 months
Mediators of the behavioral activation treatment for smoking plus nicotine replacement therapy treatment effect in low reward sensitivity- smokers
Time frame: Up to 4 months
The primary outcome measure is cigarettes per day (CPD) as measured by Time Line Follow Back. This self-report will be biochemically verified by either carbon monoxide breath sample or nicotine sample
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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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.
Jennifer A Minnix principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Intervention, Laboratory Biomarker Analysis and Nicotine Patch in people with Cigarette Smoker and Tobacco Use Disorder, run by M.D. Anderson Cancer Center 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 6 inclusion and 22 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: under way, not looking for participants, as of the sponsor's last update on 11 Jun 2026. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Effectiveness of behavioral activation treatment for smoking plus nicotine replacement therapy versus standard cessation treatment plus nicotine replacement therapy defined as abstinence rate in low reward sensitivity- and + smokers (time frame: Up to 4 months). The study lists 2 primary outcomes in all. 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 11 Jun 2026.