for Cigarette Smoking and Binge Drinking CessationNCT01184261
Integrated Behavioral Intervention for Cigarette Smoking and Binge Drinking in Young Adults
A study testing behavioral intervention in people with for Cigarette Smoking and Binge Drinking Cessation, run by Mayo Clinic at 1 site in United States.
Trial summary
RATIONALE: Nicotine patches and behavioral therapy may help reduce cigarette smoking and binge drinking in young adults. PURPOSE: This randomized clinical trial studies nicotine patches with or without behavioral therapy in reducing cigarette smoking and binge drinking in young adults. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- for Cigarette Smoking and Binge Drinking Cessation
- What is being tested?
- behavioral intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to Feb 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Inclusion Criteria: - Smoked an average of >= 10 or more cigarettes per day during the past 6 months - Binge drank on an average of >= 2 occasions per month during the past 3 months - Able to participate fully in all aspects of the intervention and keep all scheduled appointments - Willing to participate in 6 months of follow-up - Willing to stop smoking and use nicotine patch therapy - Willing to refrain from participating in additional smoking interventions for the duration of the study - Provide written informed consent Exclusion Criteria: - Current (past 90 days) alcohol dependence as assessed by the Structured Clinical Interview for DSM-IV Axis I Disorders, Alcohol Dependence Module - Current (past 12 months) non-nicotine or alcohol drug dependence as assessed by a Drug Abuse Screening Test-20 score of >= 6 - Current elevation of depressive symptoms (past 2 weeks) that would be indicative of clinical depression as assessed by a Beck Depression Inventory-II score of >= 20 - Current use (past 30 days) of nicotine containing medication or frequent use (> 10 occasions per month) of tobacco products other than cigarettes - Current use (past 30 days) of any other smoking cessation treatment involving behavioral or pharmacological interventions - Any medical condition that would preclude use of the nicotine patch including current unstable angina, recent history (past 30 days) of myocardial infarction or stroke, history of severe skin allergies, or evidence of severe chronic dermatosis - Currently pregnant or breast feeding, or likely to become pregnant during the nicotine patch phase
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Integrated Intervention for Cigarette Smoking and Binge Drinking for Young Adults
RATIONALE: Nicotine patches and behavioral therapy may help reduce cigarette smoking and binge drinking in young adults. PURPOSE: This randomized clinical trial studies nicotine patches with or without behavioral therapy in reducing cigarette smoking and binge drinking in young adults.
Read the detailed description
OBJECTIVES: I. To evaluate the efficacy of Integrated Intervention that targets both cigarette smoking and binge drinking on the cigarette smoking behavior of young adult smokers at 6-month follow-up. II. To evaluate the efficacy of Integrated Intervention that targets both cigarette smoking and binge drinking on binge drinking behavior of young adult smokers. III. Examine the effect of Integrated Intervention on several possible mediators of change corresponding to mechanisms that have been proposed to account for the relationship between cigarette smoking and alcohol use. These mediators include cravings to smoke, perceived similarity to the typical smoker, and self-efficacy for smoking abstinence. OUTLINE: Patients are randomized to 1 of 2 treatment arms.All patients receive nicotine patch therapy in weeks 4-11. ARM I: Patients attend behavioral sessions for smoking and binge drinking cessation over 30 minutes once weekly in weeks 1-6. ARM II: Patients attend behavioral sessions for smoking cessation over 30 minutes once weekly in weeks 1-6.After completion of study treatment, patients are followed up at weeks 12, 16, 20, and 24.
- Being tested
- behavioral intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
behavioral interventionBehavioural
Also called Behavior or Life Style Modifications, Behavior Therapy, Behavioral Modification, Behavioral Therapy
8 session behavioral intervention.
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | Patients attend behavioral sessions for smoking and binge drinking cessation over 30 minutes once weekly in weeks 1-6. Receives: Behavioral: behavioral intervention |
| Arm II | Experimental | Patients attend behavioral sessions for smoking cessation over 30 minutes once weekly in weeks 1-6. Receives: Behavioral: behavioral intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biochemically-confirmed 7-day point prevalence tobacco abstinence
Measured: At week 24
Secondary outcomes (2)
Effect of the integrated intervention on binge drinking
Measured: At week 24
Possible mediators of the intervention
Measured: At week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2010 (estimated)
- Study startAug 2010
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for for Cigarette Smoking and Binge Drinking CessationStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- James and Esther King Biomedical Research Program
- Responsible party
- Principal investigator, Steven Ames, Mayo Clinic
- Investigators
- Steven Ames, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01184261
- Sponsor's protocol ID
- 10-000432
- Other IDs
- NCI-2010-01881
- Status last verified
- Mar 2014
- First submitted
- 17 Aug 2010
- Last updated
- 26 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Intervention for Cigarette Smoking and Binge Drinking for Young Adults
- ClinicalTrials.gov ID
- NCT01184261
- Acronym / sponsor ID
- 10-000432
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- James and Esther King Biomedical Research Program
- Study start
- Aug 2010
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 18 Aug 2010 (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.
RATIONALE: Nicotine patches and behavioral therapy may help reduce cigarette smoking and binge drinking in young adults. PURPOSE: This randomized clinical trial studies nicotine patches with or without behavioral therapy in reducing cigarette smoking and binge drinking in young adults.
Detailed description
OBJECTIVES: I. To evaluate the efficacy of Integrated Intervention that targets both cigarette smoking and binge drinking on the cigarette smoking behavior of young adult smokers at 6-month follow-up. II. To evaluate the efficacy of Integrated Intervention that targets both cigarette smoking and binge drinking on binge drinking behavior of young adult smokers. III. Examine the effect of Integrated Intervention on several possible mediators of change corresponding to mechanisms that have been proposed to account for the relationship between cigarette smoking and alcohol use. These mediators include cravings to smoke, perceived similarity to the typical smoker, and self-efficacy for smoking abstinence. OUTLINE: Patients are randomized to 1 of 2 treatment arms.All patients receive nicotine patch therapy in weeks 4-11. ARM I: Patients attend behavioral sessions for smoking and binge drinking cessation over 30 minutes once weekly in weeks 1-6. ARM II: Patients attend behavioral sessions for smoking cessation over 30 minutes once weekly in weeks 1-6.After completion of study treatment, patients are followed up at weeks 12, 16, 20, and 24.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Behavioral: behavioral interventionPatients attend behavioral sessions for smoking and binge drinking cessation over 30 minutes once weekly in weeks 1-6. |
| Arm II | Experimental | Behavioral: behavioral interventionPatients attend behavioral sessions for smoking cessation over 30 minutes once weekly in weeks 1-6. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
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 or Life Style Modifications, Behavior Therapy, Behavioral Modification, Behavioral Therapy8 session behavioral intervention. | Behavioural | Arm I, Arm II |
Primary outcome
Biochemically-confirmed 7-day point prevalence tobacco abstinence
Time frame: At week 24
2 secondary outcomes
Effect of the integrated intervention on binge drinking
Time frame: At week 24
Possible mediators of the intervention
Time frame: At week 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2014.
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.
Steven Ames principal investigator
Mayo Clinic
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 in people with for Cigarette Smoking and Binge Drinking Cessation, run by Mayo Clinic 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?
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 26 Mar 2014. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Biochemically-confirmed 7-day point prevalence tobacco abstinence (time frame: At week 24). 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 26 Mar 2014.