Smoking CessationNCT00592085
Combined Treatment for Tobacco and Alcohol Use
A study testing Questionnaires, Motivational Relapse Prevention Counseling and Relapse Plus Alcohol Risk Reduction Counseling in people with Smoking Cessation, run by M.D. Anderson Cancer Center.
Trial summary
The specific aims are to: Develop a "Motivational Relapse Prevention Plus Alcohol Risk Reduction" (MRP+) approach to simultaneously treating both smoking and "at-risk" alcohol use among smokers attempting to quit smoking. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Questionnaires, Motivational Relapse Prevention Counseling and Relapse Plus Alcohol Risk Reduction Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2007to Nov 2008
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Current daily smoker who averages 5 or more cigarettes/day.
- Exhibit at least one of the following criteria for at-risk drinking: a) an average of > or equal to 2 alcoholic beverages/day during the past 30 days for men or > or equal to 1 drink/day for women, OR b) two or more occasions of consuming > or equal to 5 alcoholic beverages during the past 30 days for men or > or equal to 4 drinks for women, OR c) driving after consuming > or equal to 3 drinks in the past 30 days,
- Age 18 or above
- Motivated to quit smoking in the next 30 days
- Viable (working) telephone number and home address
- No other household member enrolled in this protocol
- Score equal to or less than 15 on the Alcohol Use Disorders Identification Test (AUDIT) measure.
- Must be able to speak English.
Who cannot join
- None
About this study
The specific aims are to:
- Develop a "Motivational Relapse Prevention Plus Alcohol Risk Reduction" (MRP+) approach to simultaneously treating both smoking and "at-risk" alcohol use among smokers attempting to quit smoking.
- Estimate the effect size for MRP+ relative to Motivational Relapse Prevention without a focus on alcohol (MRP) with respect to alcohol at-risk behaviors. The estimated effect size will be utilized to help guide sample size estimates for a potential clinical trial.
Read the detailed description
Study Participation If you agree to take part in this study, you will come to M. D. Anderson and use a computer to complete a series of questionnaires. You will be asked questions about your living situation, mood, depression, anxiety, appetite, smoking and alcohol use habits, social status, finances, job, physical activity, and support from family and/or friends. These questionnaires may take a total of about 1 hour to complete.
After completing the questionnaires, you will be randomly assigned (as in the toss of a coin) to one of two groups. One group will receive counseling (called motivational relapse prevention counseling), which will focus on smoking cessation. The other group will also receive counseling (called motivational relapse prevention plus alcohol risk reduction counseling), which will focus on smoking cessation as well but will also include discussion about at-risk alcohol use. Both groups will receive reading materials related to smoking cessation. The motivational relapse prevention plus alcohol risk reduction group will also receive reading materials related to alcohol use.
You will receive a total of 6 counseling calls during this study. Your first counseling call will be to set up your quit date. You will then have 5 additional counseling calls within the 12 weeks after your enrollment in the study. The timing of these calls will be determined between you and your counselor. Depending on which group you are in, you will be counseled on strategies for quitting smoking and/or decreasing alcohol use to help decrease your risk of cancer. These calls will take about 20 to 30 minutes each to complete. You will be asked to provide contact information for friends and/or relatives. The research staff will contact them only if you are unable to be contacted after multiple attempts.
Final Visit At Week 12, you will be requested to return to M. D. Anderson to complete the last computerized series of questionnaires.
Your counseling calls will be tape recorded so researchers can make sure that correct procedures are being followed. Only the study staff will be allowed to listen to these tapes. Your identity will be kept secure and confidential. These tapes will be erased when this study has ended.
Study Length Your participation in this study will be over after the evaluation visit at Week 12.
- Conditions
- Smoking Cessation
- Being tested
- Questionnaires, Motivational Relapse Prevention Counseling, Relapse Plus Alcohol Risk Reduction Counseling
- Keywords
- Tobacco Use, Smoking, Alcohol Use, Smoking Cessation
- Medical subject headings
- Smoking Cessation, Tobacco Use, Smoking, Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesBehavioural
Participants will use a computer to complete a series of questionnaires.
Motivational Relapse Prevention CounselingBehavioural
Total of 6 counseling calls for Smoking Relapse: First counseling call will be to set up your quit date; then 5 additional counseling calls within 12 weeks after enrollment, each 20 to 30 minutes to complete.
Relapse Plus Alcohol Risk Reduction CounselingBehavioural
Total of 6 counseling calls for both Smoking Relapse and Alcohol Risk: First counseling call will be to set up your quit date; then 5 additional counseling calls within 12 weeks after enrollment, each 20 to 30 minutes to complete.
| Study group | Role | What they receive |
|---|---|---|
| Relapse Prevention Counseling | Active comparator | Motivational Relapse Counseling: 6 counseling calls over two weeks accompanied by questionnaires Receives: Behavioral: Questionnaires; Behavioral: Motivational Relapse Prevention Counseling |
| Relapse Prevention + Alcohol Counseling | Active comparator | Motivational Relapse Prevention Plus Alcohol Risk Reduction Counseling: 6 counseling calls over two weeks for both smoking cessation and at-risk alcohol use accompanied by questionnaires Receives: Behavioral: Questionnaires; Behavioral: Relapse Plus Alcohol Risk Reduction Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall at-risk drinking status
At-risk drinking, defined by National Institute on Alcohol Abuse and Alcoholism, refers to a constellation of alcohol use behaviors that increase risk for physical and psychosocial problems including (a) an average of > 2 alcoholic beverages/day during the past 30 days for men or >1 drink/day for women, OR (b) two or more occasions of consuming > 5 alcoholic beverages during the past 30 days for men or >4 drinks for women, OR (c) driving after consuming >3 drinks in the past 30 days.
Measured: Baseline and Week 12
Secondary outcomes (1)
Effectiveness of certain type of telephone counseling ability to help participants decrease both their smoking and at-risk alcohol use as measured by Smoking Cessation and At-Risk Drinking Evaulation
Effectiveness evaluated using descriptive data from questionnaires to evaluate theoretically- and empirically-based "Motivational Relapse Prevention Plus Alcohol Risk Reduction" (MRP+) approach for simultaneously intervening on both smoking and at risk alcohol use. Evaluation through questionnaire results, smoking cessation and overall at-risk drinking status, a dichotomous variable defined previously.
Measured: Up to 3 months for baseline and repeat assessments at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2008 (estimated)
- Study startDec 2007
- Primary completionNov 2008
- Study completionNov 2008
Why it stopped: No patients registered; study terminated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies 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
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Wetter, PHD, MS, BA, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00592085
- Sponsor's protocol ID
- 2007-0111
- Status last verified
- Sep 2009
- First submitted
- 27 Dec 2007
- Last updated
- 20 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Treatment for Tobacco and Alcohol Use
- ClinicalTrials.gov ID
- NCT00592085
- Acronym / sponsor ID
- 2007-0111
- Conditions
- Smoking Cessation
- Keywords
- Tobacco Use, Smoking, Alcohol Use, Smoking Cessation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No patients registered; study terminated.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Dec 2007
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 11 Jan 2008 (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.
The specific aims are to:
- Develop a "Motivational Relapse Prevention Plus Alcohol Risk Reduction" (MRP+) approach to simultaneously treating both smoking and "at-risk" alcohol use among smokers attempting to quit smoking.
- Estimate the effect size for MRP+ relative to Motivational Relapse Prevention without a focus on alcohol (MRP) with respect to alcohol at-risk behaviors. The estimated effect size will be utilized to help guide sample size estimates for a potential clinical trial.
Detailed description
Study Participation If you agree to take part in this study, you will come to M. D. Anderson and use a computer to complete a series of questionnaires. You will be asked questions about your living situation, mood, depression, anxiety, appetite, smoking and alcohol use habits, social status, finances, job, physical activity, and support from family and/or friends. These questionnaires may take a total of about 1 hour to complete.
After completing the questionnaires, you will be randomly assigned (as in the toss of a coin) to one of two groups. One group will receive counseling (called motivational relapse prevention counseling), which will focus on smoking cessation. The other group will also receive counseling (called motivational relapse prevention plus alcohol risk reduction counseling), which will focus on smoking cessation as well but will also include discussion about at-risk alcohol use. Both groups will receive reading materials related to smoking cessation. The motivational relapse prevention plus alcohol risk reduction group will also receive reading materials related to alcohol use.
You will receive a total of 6 counseling calls during this study. Your first counseling call will be to set up your quit date. You will then have 5 additional counseling calls within the 12 weeks after your enrollment in the study. The timing of these calls will be determined between you and your counselor. Depending on which group you are in, you will be counseled on strategies for quitting smoking and/or decreasing alcohol use to help decrease your risk of cancer. These calls will take about 20 to 30 minutes each to complete. You will be asked to provide contact information for friends and/or relatives. The research staff will contact them only if you are unable to be contacted after multiple attempts.
Final Visit At Week 12, you will be requested to return to M. D. Anderson to complete the last computerized series of questionnaires.
Your counseling calls will be tape recorded so researchers can make sure that correct procedures are being followed. Only the study staff will be allowed to listen to these tapes. Your identity will be kept secure and confidential. These tapes will be erased when this study has ended.
Study Length Your participation in this study will be over after the evaluation visit at Week 12.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Relapse Prevention Counseling | Active comparator | Behavioral: Questionnaires, Behavioral: Motivational Relapse Prevention CounselingMotivational Relapse Counseling: 6 counseling calls over two weeks accompanied by questionnaires |
| Relapse Prevention + Alcohol Counseling | Active comparator | Behavioral: Questionnaires, Behavioral: Relapse Plus Alcohol Risk Reduction CounselingMotivational Relapse Prevention Plus Alcohol Risk Reduction Counseling: 6 counseling calls over two weeks for both smoking cessation and at-risk alcohol use accompanied by questionnaires |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Current daily smoker who averages 5 or more cigarettes/day.
- Exhibit at least one of the following criteria for at-risk drinking: a) an average of > or equal to 2 alcoholic beverages/day during the past 30 days for men or > or equal to 1 drink/day for women, OR b) two or more occasions of consuming > or equal to 5 alcoholic beverages during the past 30 days for men or > or equal to 4 drinks for women, OR c) driving after consuming > or equal to 3 drinks in the past 30 days,
- Age 18 or above
- Motivated to quit smoking in the next 30 days
- Viable (working) telephone number and home address
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| QuestionnairesParticipants will use a computer to complete a series of questionnaires. | Behavioural | Relapse Prevention + Alcohol Counseling, Relapse Prevention Counseling |
| Motivational Relapse Prevention CounselingTotal of 6 counseling calls for Smoking Relapse: First counseling call will be to set up your quit date; then 5 additional counseling calls within 12 weeks after enrollment, each 20 to 30 minutes to complete. | Behavioural | Relapse Prevention Counseling |
| Relapse Plus Alcohol Risk Reduction CounselingTotal of 6 counseling calls for both Smoking Relapse and Alcohol Risk: First counseling call will be to set up your quit date; then 5 additional counseling calls within 12 weeks after enrollment, each 20 to 30 minutes to complete. | Behavioural | Relapse Prevention + Alcohol Counseling |
Primary outcome
Overall at-risk drinking status
Time frame: Baseline and Week 12
At-risk drinking, defined by National Institute on Alcohol Abuse and Alcoholism, refers to a constellation of alcohol use behaviors that increase risk for physical and psychosocial problems including (a) an average of > 2 alcoholic beverages/day during the past 30 days for men or >1 drink/day for women, OR (b) two or more occasions of consuming > 5 alcoholic beverages during the past 30 days for men or >4 drinks for women, OR (c) driving after consuming >3 drinks in the past 30 days.
1 secondary outcome
Effectiveness of certain type of telephone counseling ability to help participants decrease both their smoking and at-risk alcohol use as measured by Smoking Cessation and At-Risk Drinking Evaulation
Time frame: Up to 3 months for baseline and repeat assessments at 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2016.
- 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.
David Wetter, PHD, MS, BA principal investigator
M.D. Anderson Cancer Center
Questions about this trial
What is this clinical trial studying?
A study testing Questionnaires, Motivational Relapse Prevention Counseling and Relapse Plus Alcohol Risk Reduction Counseling in people with Smoking Cessation, run by M.D. Anderson Cancer Center.
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 8 inclusion and 1 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: withdrawn, as of the sponsor's last update on 20 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Overall at-risk drinking status (time frame: Baseline and Week 12). 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 20 Jul 2016.