Tobacco Use CessationPhase 2NCT00861146
Concurrent Alcohol and Smoking Treatment: Effects on Alcohol Relapse Risk
A Phase 2 study testing behavioral counseling plus contingency management in people with Tobacco Use Cessation and Alcohol-related Disorders, run by Yale University at 2 sites in United States.
Trial summary
The majority of individuals with alcohol problems remain current smokers, and the negative health consequences of smoking among these individuals are substantial. This study will investigate the impact of smoking cessation interventions initiated during intensive alcohol treatment on processes reflecting risk of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tobacco Use Cessation, Alcohol-related Disorders
- What is being tested?
- behavioral counseling plus contingency management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 151 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2009to Mar 2013
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- DSM-IV criteria for alcohol abuse or dependence
- Age 18 or older
- English speaking
- Smoking 1 or more cigarettes/day
- Male or female veterans eligible for VA healthcare
- Female nonveterans also eligible
Who cannot join
- Allergy or hypersensitivity to nicotine or adhesives used in nicotine patch
- Weigh less than 100 lbs
- Lack of interest in stopping smoking
- Pregnant or lactating females or females not practicing acceptable form of contraception
Trial locations and contacts
2 sites in 1 country.
United States2 sites
VA Connecticut Healthcare System
Newington, Connecticut, 06111
VA Connecticut Healthcare System
West Haven, Connecticut, 06516
About this study
The majority of individuals with alcohol problems remain current smokers, and the negative health consequences of smoking among these individuals are substantial. This study will investigate the impact of smoking cessation interventions initiated during intensive alcohol treatment on processes reflecting risk of alcohol relapse.
Read the detailed description
Objectives:
Most alcohol and drug treatment programs do not systematically address cigarette smoking during treatment. One obstacle is a concern that smoking cessation early in recovery might increase risk of alcohol relapse. This study followed patients enrolled in intensive outpatient alcohol treatment to compare the effects of a Concurrent Smoking Cessation (CSC) intervention to a Deferred Smoking Cessation (DSC) control group on process measures reflecting risk of alcohol relapse.
Research Design:
Participants were enrolled in intensive outpatient alcohol treatment and then randomized to CSC or DSC groups in a 2:1 ratio. The CSC group received smoking treatment concurrent with intensive alcohol treatment and the DSC group received smoking treatment three months after alcohol treatment. The smoking treatment protocol included behavioral counseling, contingency management with voucher rewards for verified smoking abstinence, and prescribed nicotine patch and gum. During a three-month period after the CSC target smoking quit date, both groups of subjects were asked to participate in a prospective daily monitoring procedure, calling into an Interactive Voice Response system once a day to complete self-report assessments of relapse risk factors. By comparing participants in the CSC group composed of many participants who have stopped smoking with the DSC group who are expected to continue smoking during this daily monitoring period, we will determine the impact of smoking cessation on alcohol relapse risk factors.
Methodology:
This study was conducted in the substance abuse day treatment programs located at Newington and West Haven campuses of VA Connecticut Healthcare System. These are three-week treatment programs meeting Monday-Friday for 4-5 hrs/day. Participants were recruited either before or soon after day program admission. Participants 151 individuals that are 18 years of age or older, meet Diagnostic and Statistical Manual-IV (DSM-IV) criteria for current alcohol abuse or dependence, report currently smoking 1 or more cigarettes per day, and are screened for medical contraindications for nicotine patch and gum use. Dependent variables are process assessments reflecting alcohol relapse risk obtained using daily Interactive Voice Response (IVR) technology. These relapse risk processes include alcohol craving, negative affect, alcohol abstinence self efficacy, alcohol outcome expectancies, motivation for alcohol abstinence, and self-control demands. Given the mixed results from previous clinical trials, we conducted bidirectional tests of the hypothesis that smoking cessation has an impact on alcohol relapse risk factors, examining whether smoking cessation leads to increased or decreased alcohol relapse risk.
- Conditions
- Tobacco Use Cessation, Alcohol-related Disorders
- Being tested
- behavioral counseling plus contingency management
- Keywords
- nicotine dependence, tobacco dependence, smoking cessation, alcoholism, self-efficacy, relapse
- Medical subject headings
- Tobacco Use Cessation, Alcohol-Related Disorders, Tobacco Use Disorder, Smoking Cessation, Alcoholism, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
behavioral counseling plus contingency managementBehavioural
Individual counseling sessions with voucher rewards for smoking abstinence, transdermal nicotine patch and nicotine gum
| Study group | Role | What they receive |
|---|---|---|
| 1 concurrent smoking cessation | Experimental | smoking cessation delivered concurrent with intensive alcohol treatment Receives: Behavioral: behavioral counseling plus contingency management |
| 2 deferred smoking cessation | Active comparator | smoking cessation delivered 12 weeks after intensive alcohol treatment Receives: Behavioral: behavioral counseling plus contingency management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking Abstinence
7-day point prevalence smoking abstinence verified by breath carbon monoxide missing coded as smoking
Measured: 12 weeks
Smoking Abstinence
7-day point prevalence smoking abstinence verified by breath carbon monoxide missing coded as smoking
Measured: 2 weeks
Secondary outcomes (1)
Proportion of Days Heavy Drinking
Heavy drinking days were defined as days with > 6 standard drinks per day for men and > 4 standard drinks per day for women. This measure examined the proportion of days heavy drinking across 28 days in follow-up weeks 9-12.
Measured: follow-up weeks 9-12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2009 (estimated)
- Study startApr 2009
- Primary completionMar 2013
- Study completionMar 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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tobacco Use CessationStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- Ned L Cooney, PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00861146
- Sponsor's protocol ID
- 0804003723
- Other IDs
- R01AA011197
- Status last verified
- Apr 2020
- First submitted
- 11 Mar 2009
- Last updated
- 3 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Cooney NL, Litt MD, Sevarino KA, Levy L, Kranitz LS, Sackler H, Cooney JL. Concurrent alcohol and tobacco treatment: Effect on daily process measures of alcohol relapse risk. J Consult Clin Psychol. 2015 Apr;83(2):346-58. doi: 10.1037/a0038633. Epub 2015 Jan 26.
PubMed 25622198
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Concurrent Alcohol and Smoking Treatment: Effects on Alcohol Relapse Risk
- ClinicalTrials.gov ID
- NCT00861146
- Acronym / sponsor ID
- 0804003723
- Conditions
- Tobacco Use Cessation, Alcohol-related Disorders
- Keywords
- nicotine dependence, tobacco dependence, smoking cessation, alcoholism, self-efficacy, relapse
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Apr 2009
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 13 Mar 2009 (estimated)
- Results
- Posted 7 Apr 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The majority of individuals with alcohol problems remain current smokers, and the negative health consequences of smoking among these individuals are substantial. This study will investigate the impact of smoking cessation interventions initiated during intensive alcohol treatment on processes reflecting risk of alcohol relapse.
Detailed description
Objectives:
Most alcohol and drug treatment programs do not systematically address cigarette smoking during treatment. One obstacle is a concern that smoking cessation early in recovery might increase risk of alcohol relapse. This study followed patients enrolled in intensive outpatient alcohol treatment to compare the effects of a Concurrent Smoking Cessation (CSC) intervention to a Deferred Smoking Cessation (DSC) control group on process measures reflecting risk of alcohol relapse.
Research Design:
Participants were enrolled in intensive outpatient alcohol treatment and then randomized to CSC or DSC groups in a 2:1 ratio. The CSC group received smoking treatment concurrent with intensive alcohol treatment and the DSC group received smoking treatment three months after alcohol treatment. The smoking treatment protocol included behavioral counseling, contingency management with voucher rewards for verified smoking abstinence, and prescribed nicotine patch and gum. During a three-month period after the CSC target smoking quit date, both groups of subjects were asked to participate in a prospective daily monitoring procedure, calling into an Interactive Voice Response system once a day to complete self-report assessments of relapse risk factors. By comparing participants in the CSC group composed of many participants who have stopped smoking with the DSC group who are expected to continue smoking during this daily monitoring period, we will determine the impact of smoking cessation on alcohol relapse risk factors.
Methodology:
This study was conducted in the substance abuse day treatment programs located at Newington and West Haven campuses of VA Connecticut Healthcare System. These are three-week treatment programs meeting Monday-Friday for 4-5 hrs/day. Participants were recruited either before or soon after day program admission. Participants 151 individuals that are 18 years of age or older, meet Diagnostic and Statistical Manual-IV (DSM-IV) criteria for current alcohol abuse or dependence, report currently smoking 1 or more cigarettes per day, and are screened for medical contraindications for nicotine patch and gum use. Dependent variables are process assessments reflecting alcohol relapse risk obtained using daily Interactive Voice Response (IVR) technology. These relapse risk processes include alcohol craving, negative affect, alcohol abstinence self efficacy, alcohol outcome expectancies, motivation for alcohol abstinence, and self-control demands. Given the mixed results from previous clinical trials, we conducted bidirectional tests of the hypothesis that smoking cessation has an impact on alcohol relapse risk factors, examining whether smoking cessation leads to increased or decreased alcohol relapse risk.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 concurrent smoking cessation | Experimental | Behavioral: behavioral counseling plus contingency managementsmoking cessation delivered concurrent with intensive alcohol treatment |
| 2 deferred smoking cessation | Active comparator | Behavioral: behavioral counseling plus contingency managementsmoking cessation delivered 12 weeks after intensive alcohol treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- DSM-IV criteria for alcohol abuse or dependence
- Age 18 or older
- English speaking
- Smoking 1 or more cigarettes/day
- Male or female veterans eligible for VA healthcare
Key exclusion criteria (4 listed)
- Allergy or hypersensitivity to nicotine or adhesives used in nicotine patch
- Weigh less than 100 lbs
- Lack of interest in stopping smoking
- Pregnant or lactating females or females not practicing acceptable form of contraception
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 counseling plus contingency managementIndividual counseling sessions with voucher rewards for smoking abstinence, transdermal nicotine patch and nicotine gum | Behavioural | 1 concurrent smoking cessation, 2 deferred smoking cessation |
Primary outcome
Smoking Abstinence
Time frame: 12 weeks
7-day point prevalence smoking abstinence verified by breath carbon monoxide missing coded as smoking
Smoking Abstinence
Time frame: 2 weeks
7-day point prevalence smoking abstinence verified by breath carbon monoxide missing coded as smoking
1 secondary outcome
Proportion of Days Heavy Drinking
Time frame: follow-up weeks 9-12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25622198Cooney NL, Litt MD, Sevarino KA, Levy L, Kranitz LS, Sackler H, Cooney JL. Concurrent alcohol and tobacco treatment: Effect on daily process measures of alcohol relapse risk. J Consult Clin Psychol. 2015 Apr;83(2):346-58. doi: 10.1037/a0038633. Epub 2015 Jan 26.
Related trials for Tobacco Use Cessation
Not yet recruitingObservational study
PROMETHEE: A Shared Interregional Tele-Tobacco Cessation Platform Embedded Within the IMPULSION Lung Cancer Screening Program
Smoking Cessation, Lung Cancer Screening
Not yet recruiting
Impacto 2.0: Mobile Smoking Cessation Across Texas
Cigarette Smoking, Smoking Cessation
Active, not recruiting
Vaping Cessation Using the Ottawa Model for Smoking Cessation Among E-Cigarette Users
Tobacco Smoking, Vaping
Recruiting
Young Adult Tobacco/Nicotine and Cannabis Co-use
Tobacco Use Disorder, Nicotine Dependence
Recruiting
Social Media Support Groups for Adolescent Vaping Cessation
Vaping, Vaping Cessation
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.
Ned L Cooney, PhD principal investigator
Yale University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing behavioral counseling plus contingency management in people with Tobacco Use Cessation and Alcohol-related Disorders, run by Yale University at 2 sites 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 4 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 3 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 7 Apr 2014). 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?
Smoking Abstinence (time frame: 12 weeks). 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?
On the ClinicalTrials.gov record for NCT00861146, which also lists 1 linked publication.
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 3 Apr 2020.