Tobacco Use DisorderNCT00217984
Intensive Intervention for Smokers - 6
A study testing Extended cognitive behavior therapy in people with Tobacco Use Disorder and Alcohol Dependence, run by University of California, San Francisco at 1 site in United States.
Trial summary
The purpose of this study was to determine the efficacy and cost-effectiveness of an intensive smoking cessation intervention that utilizes extended cognitive-behavioral therapy and combination nicotine replacement (CNR) in a randomized controlled trial. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Tobacco Use Disorder, Alcohol Dependence
- What is being tested?
- Extended cognitive behavior therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2006to Jun 2010
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- at least 18 years of age
- alcohol as primary drug of abuse
- currently smoking at least 10 or more cigarettes
- abstinent from alcohol for at least 7 days and not more than 30 days
- self-reported interest in quitting smoking
Who cannot join
- any contraindications for nicotine patches or lozenges (e.g., unstable angina or recent myocardial infarction
- skin allergy to the nicotine patch
- severe cardiovascular disease
- lactation
- pregnancy by self-report or by positive serum pregnancy test in pre-menopausal women)
- unstable psychiatric disorder
- severe cognitive impairment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intensive Intervention for Smokers in Alcohol Treatment
The purpose of this study was to determine the efficacy and cost-effectiveness of an intensive smoking cessation intervention that utilizes extended cognitive-behavioral therapy and combination nicotine replacement (CNR) in a randomized controlled trial. The intensive intervention was compared to usual care involving referral to a free-standing smoking cessation program that provides brief counseling and CNR. We recruited 162 smokers, ages 18 to 75, who are enrolled in the Drug and Alcohol Treatment (DAT) programs at the San Francisco VA Medical Center (SFVAMC) and Santa Rosa VA Community-based Outpatient Clinic (CBOC). To be eligible, participants had to be abstinent from alcohol for at least one week, but not more than 30 days. We compared outcomes for the two study arms by assessing biochemically-validated point-prevalence smoking status at 3, 6, 9, and 12 months post-baseline and continuous abstinence over the 12-month follow-up. Expired-air carbon monoxide (CO) was used to biochemically verify 7-day point prevalence abstinence. We also conducted an economic analysis to determine the cost-effectiveness of the intensive intervention compared with usual care. We also examined cross-relapse patterns during the follow-up period, assessing changes in mood states and use of tobacco, alcohol, and other drugs at 3, 6, 9, and 12 months.
Read the detailed description
Introduction. The purpose of this study was to investigate the efficacy of an intensive tobacco cessation intervention for alcohol-dependent smokers in early recovery.
Methods. A total of 162 alcohol-dependent smokers were randomized to either intensive intervention for smoking cessation or usual care. The intensive intervention consisted of 16 sessions of individual cognitive behavior therapy (CBT) and combination nicotine replacement therapy that lasted 26 weeks. Usual care involved referral to a free-standing smoking cessation program that provided smoking cessation counseling of varying duration and guideline-concordant medications. The primary cessation outcome was verified 7-day point prevalence abstinence (PPA) at 12, 26, 38, and 52 weeks.
Results. At 12 and 26 weeks, the verified 7-day point-prevalence quit rate was significantly higher for the intensive intervention group than for the usual care group (both p = .03). However, the quit rates for the two treatment groups were not significantly different at 38 or 52 weeks. Verified 30-day alcohol abstinence rates were not significantly different for the two treatment groups at any of the follow-up assessments.
Conclusions. The intensive smoking cessation intervention yielded a higher short-term smoking quit rate without jeopardizing sobriety. A chronic care model might facilitate maintenance of smoking cessation during the first year of alcohol treatment and perhaps for longer periods of time. It is hoped that studies such as this will inform the development of more effective interventions for concurrent alcohol and tobacco use disorders.
- Conditions
- Tobacco Use Disorder, Alcohol Dependence
- Being tested
- Usual Care, Extended cognitive behavior therapy
- Keywords
- Tobacco use disorder, Alcohol dependence
- Medical subject headings
- Tobacco Use Disorder, Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual CareOther
Also called Smoking cessation clinic
Referral to smoking cessation clinic
Extended cognitive behavior therapyBehavioural
16 sessions of cognitive behavior therapy over 6 months
| Study group | Role | What they receive |
|---|---|---|
| Intensive intervention | Experimental | Extended cognitive behavior therapy (16 sessions) plus nicotine patches and lozenges Receives: Behavioral: Extended cognitive behavior therapy |
| Usual care | Other | Referral to the smoking cessation clinic Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
7 day point prevalence of cigarette abstinence
Participants are asked whether they smoked any cigarettes during the past seven days. Expired-air carbon monoxide is measured to validate abstinence.
Measured: Assessed at 3, 6, 9, and 12 months
Secondary outcomes (1)
Alcohol use
Participants were asked to report use of alcohol during the past 90 days, using a timeline follow-back interview method
Measured: Assessed at 3, 6, 9, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startJul 2006
- Primary completionJun 2009
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco Use DisorderStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Timothy Carmody, Ph.D., Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00217984
- Sponsor's protocol ID
- NIDA-09253-6
- Other IDs
- P50DA009253
- Status last verified
- Oct 2017
- First submitted
- 16 Sep 2005
- Last updated
- 1 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensive Intervention for Smokers in Alcohol Treatment
- ClinicalTrials.gov ID
- NCT00217984
- Acronym / sponsor ID
- NIDA-09253-6
- Conditions
- Tobacco Use Disorder, Alcohol Dependence
- Keywords
- Tobacco use disorder, Alcohol dependence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Jul 2006
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 22 Sep 2005 (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 purpose of this study was to determine the efficacy and cost-effectiveness of an intensive smoking cessation intervention that utilizes extended cognitive-behavioral therapy and combination nicotine replacement (CNR) in a randomized controlled trial. The intensive intervention was compared to usual care involving referral to a free-standing smoking cessation program that provides brief counseling and CNR. We recruited 162 smokers, ages 18 to 75, who are enrolled in the Drug and Alcohol Treatment (DAT) programs at the San Francisco VA Medical Center (SFVAMC) and Santa Rosa VA Community-based Outpatient Clinic (CBOC). To be eligible, participants had to be abstinent from alcohol for at least one week, but not more than 30 days. We compared outcomes for the two study arms by assessing biochemically-validated point-prevalence smoking status at 3, 6, 9, and 12 months post-baseline and continuous abstinence over the 12-month follow-up. Expired-air carbon monoxide (CO) was used to biochemically verify 7-day point prevalence abstinence. We also conducted an economic analysis to determine the cost-effectiveness of the intensive intervention compared with usual care. We also examined cross-relapse patterns during the follow-up period, assessing changes in mood states and use of tobacco, alcohol, and other drugs at 3, 6, 9, and 12 months.
Detailed description
Introduction. The purpose of this study was to investigate the efficacy of an intensive tobacco cessation intervention for alcohol-dependent smokers in early recovery.
Methods. A total of 162 alcohol-dependent smokers were randomized to either intensive intervention for smoking cessation or usual care. The intensive intervention consisted of 16 sessions of individual cognitive behavior therapy (CBT) and combination nicotine replacement therapy that lasted 26 weeks. Usual care involved referral to a free-standing smoking cessation program that provided smoking cessation counseling of varying duration and guideline-concordant medications. The primary cessation outcome was verified 7-day point prevalence abstinence (PPA) at 12, 26, 38, and 52 weeks.
Results. At 12 and 26 weeks, the verified 7-day point-prevalence quit rate was significantly higher for the intensive intervention group than for the usual care group (both p = .03). However, the quit rates for the two treatment groups were not significantly different at 38 or 52 weeks. Verified 30-day alcohol abstinence rates were not significantly different for the two treatment groups at any of the follow-up assessments.
Conclusions. The intensive smoking cessation intervention yielded a higher short-term smoking quit rate without jeopardizing sobriety. A chronic care model might facilitate maintenance of smoking cessation during the first year of alcohol treatment and perhaps for longer periods of time. It is hoped that studies such as this will inform the development of more effective interventions for concurrent alcohol and tobacco use disorders.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensive intervention | Experimental | Behavioral: Extended cognitive behavior therapyExtended cognitive behavior therapy (16 sessions) plus nicotine patches and lozenges |
| Usual care | Other | Other: Usual CareReferral to the smoking cessation clinic |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- at least 18 years of age
- alcohol as primary drug of abuse
- currently smoking at least 10 or more cigarettes
- abstinent from alcohol for at least 7 days and not more than 30 days
- self-reported interest in quitting smoking
Key exclusion criteria (7 listed)
- any contraindications for nicotine patches or lozenges (e.g., unstable angina or recent myocardial infarction
- skin allergy to the nicotine patch
- severe cardiovascular disease
- lactation
- pregnancy by self-report or by positive serum pregnancy test in pre-menopausal women)
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 |
|---|---|---|
| Usual CareAlso: Smoking cessation clinicReferral to smoking cessation clinic | Other | Usual care |
| Extended cognitive behavior therapy16 sessions of cognitive behavior therapy over 6 months | Behavioural | Intensive intervention |
Primary outcome
7 day point prevalence of cigarette abstinence
Time frame: Assessed at 3, 6, 9, and 12 months
Participants are asked whether they smoked any cigarettes during the past seven days. Expired-air carbon monoxide is measured to validate abstinence.
1 secondary outcome
Alcohol use
Time frame: Assessed at 3, 6, 9, and 12 months
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 1 Nov 2017.
Related trials for Tobacco Use Disorder
Recruiting
Advanced Functional and Structural MRI Techniques for Neuropharmacological Imaging
Drug Abuse, Nicotine Dependence
Not yet recruitingObservational study
Neurostructural and Biochemical Signatures of Tobacco Smoking in Mood Disorders
Major Depressive Disorder, Bipolar Disorder
Recruiting
EFFECTIVENESS OF VOLITIONAL HELP SHEETS AS AN ADJUNCT TO TREATMENT TO PROMOTE BEHAVIOR CHANGE: A PILOT STUDY ON SMOKING
Tobacco Dependence
RecruitingObservational study
§SMOKE Nicotine and Tobacco Youth Cohort
Tobacco Use Behavior, Nicotine Dependence Tobacco Product
Active, not recruitingPhase 3
Early Withdrawal Exposure and Negative Affect Withdrawal (NAW) Regulation Training for Smoking Cessation
Tobacco Dependence
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.
Timothy Carmody, Ph.D. principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extended cognitive behavior therapy in people with Tobacco Use Disorder and Alcohol Dependence, run by University of California, San Francisco 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 7 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 1 Nov 2017. 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?
7 day point prevalence of cigarette abstinence (time frame: Assessed at 3, 6, 9, and 12 months). 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 1 Nov 2017.