Tobacco Use DisorderPhase 2NCT00107575
Improving Smoking Cessation Outcomes in Heavy Drinkers - 1
A Phase 2 study testing Standard treatment plus brief alcohol intervention and Standard treatment (ST) in people with Tobacco Use Disorder, run by Brown University at 1 site in United States.
Trial summary
To test the effectiveness of an smoking cessation treatment for smokers who also drink alcohol heavily. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Tobacco Use Disorder
- What is being tested?
- Standard treatment plus brief alcohol intervention and Standard treatment (ST)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 236 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2003to Apr 2008
- 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 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- be at least 18 years of age
- have smoked cigarettes regularly for at least one year
- currently smoke at least 10 cigarettes a day
- currently be using no other tobacco products or nicotine replacement therapy
- currently drink heavily according to self-report (>14 drinks per week or >5 drinks per occasion at least once per month over the last 12 months for men; >7 drinks per week or >4 drinks per occasion at least once per month over the past 12 months for women)
Who cannot join
- meet full DSM-IV criteria for alcohol dependence in the past 12 months
- meet criteria for other current psychoactive substance abuse or dependence (excluding nicotine dependence and alcohol abuse) in the past 12 months [this would also exclude individuals with lifetime substance dependence who continue to have some abuse/dependence symptoms in the past 12 months]
- meet criteria for current dysthymia, major depression, or manic episode [past month]
- are currently psychotic [past 12 months] or suicidal [suicidal ideation or intent in the past month]
- have an unstable medical condition that would suggest caution in the use of the nicotine patch (e.g., unstable angina pectoris, arrhythmia, recent congestive heart failure)
- are currently pregnant or lactating or intend to become pregnant. We also will exclude participants who are not alcohol dependent but who have characteristics that might make supervised alcohol detoxification necessary (e.g., morning drinking to avoid withdrawal, daily drinking of >12 drinks, recent withdrawal symptoms, history of severe withdrawal symptoms such as hallucinations, seizures, or delirium tremens).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improving Smoking Cessation Outcomes in Heavy Drinkers
To test the effectiveness of an smoking cessation treatment for smokers who also drink alcohol heavily.
Read the detailed description
Heavy alcohol use frequently co-occurs with cigarette smoking and may impede smoking cessation. This clinical trial examined whether smoking cessation treatment that incorporates brief alcohol intervention can improve smoking cessation outcomes (7-day verified point prevalence abstinence) and reduce drinks consumed per week. Heavy drinkers seeking smoking cessation treatment were assigned by urn randomization to receive, along with 8-weeks of nicotine replacement therapy, either a 4-session standard smoking cessation treatment (ST, n = 119) or standard treatment of equal intensity that incorporated brief alcohol intervention (ST-BI, n = 117).
- Conditions
- Tobacco Use Disorder
- Being tested
- Standard treatment plus brief alcohol intervention, Standard treatment (ST)
- Keywords
- tobacco, alcohol
- 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.
Standard treatment plus brief alcohol interventionBehavioural
Standard smoking cessation treatment with nicotine patch plus a brief alcohol-focused intervention
Standard treatment (ST)Other
Behavioral smoking cessation counseling and nicotine patch.
| Study group | Role | What they receive |
|---|---|---|
| Standard treatment (ST) | Active comparator | Standard smoking cessation treatment (ST) Receives: Other: Standard treatment (ST) |
| ST-BI | Experimental | Standard treatment plus a brief alcohol intervention Receives: Behavioral: Standard treatment plus brief alcohol intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking Abstinence at 26 Weeks
7 days of smoking abstinence confirmed biochemically at 26 week post quit attempt
Measured: 26 weeks
Smoking Abstinence at 16 Weeks
7 days of smoking abstinence confirmed biochemically at 16 weeks
Measured: 16 weeks
Smoking Abstinence at 8 Weeks
7 days of smoking abstinence confirmed biochemically at 8 weeks
Measured: 8 weeks
Smoking Abstinence at 2 Weeks
7 days of smoking abstinence confirmed biochemically at 2 weeks
Measured: 2 weeks
Secondary outcomes (1)
Alcohol Drinks Consumed Per Week Over a 2-week Period
Average number of standard alcoholic drinks consumed per week over each 2-week period across the 26 weeks of follow-up as assessed by the Timeline Followback Interview. Standard alcoholic drink is defined as 12 oz of beer, 5 oz of wine, or 1.5 ounces of liquor.
Measured: At 2, 8, 16, and 26-week follow-ups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2005 (estimated)
- Study startAug 2003
- Primary completionJun 2007
- Study completionApr 2008
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 DisorderStudies of the same condition, open and under way.
- More trials run by Brown 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
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 236 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher W. Kahler, Brown University
- Investigators
- Christopher W Kahler, Ph.D., Principal investigator, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00107575
- Sponsor's protocol ID
- NIDA-15534-1
- Other IDs
- R01-15534-1
- Status last verified
- Sep 2016
- First submitted
- 5 Apr 2005
- Last updated
- 26 Oct 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Kahler CW, Metrik J, LaChance HR, Ramsey SE, Abrams DB, Monti PM, Brown RA. Addressing heavy drinking in smoking cessation treatment: a randomized clinical trial. J Consult Clin Psychol. 2008 Oct;76(5):852-62. doi: 10.1037/a0012717.
PubMed 18837602
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Smoking Cessation Outcomes in Heavy Drinkers
- ClinicalTrials.gov ID
- NCT00107575
- Acronym / sponsor ID
- NIDA-15534-1
- Conditions
- Tobacco Use Disorder
- Keywords
- tobacco, alcohol
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 236 participants (actual)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Study start
- Aug 2003
- Primary completion
- Jun 2007 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 6 Apr 2005 (estimated)
- Results
- Posted 11 Jan 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To test the effectiveness of an smoking cessation treatment for smokers who also drink alcohol heavily.
Detailed description
Heavy alcohol use frequently co-occurs with cigarette smoking and may impede smoking cessation. This clinical trial examined whether smoking cessation treatment that incorporates brief alcohol intervention can improve smoking cessation outcomes (7-day verified point prevalence abstinence) and reduce drinks consumed per week. Heavy drinkers seeking smoking cessation treatment were assigned by urn randomization to receive, along with 8-weeks of nicotine replacement therapy, either a 4-session standard smoking cessation treatment (ST, n = 119) or standard treatment of equal intensity that incorporated brief alcohol intervention (ST-BI, n = 117).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard treatment (ST) | Active comparator | Other: Standard treatment (ST)Standard smoking cessation treatment (ST) |
| ST-BI | Experimental | Behavioral: Standard treatment plus brief alcohol interventionStandard treatment plus a brief alcohol intervention |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- be at least 18 years of age
- have smoked cigarettes regularly for at least one year
- currently smoke at least 10 cigarettes a day
- currently be using no other tobacco products or nicotine replacement therapy
- currently drink heavily according to self-report (>14 drinks per week or >5 drinks per occasion at least once per month over the last 12 months for men; >7 drinks per week or >4 drinks per occasion at least once per month over the past 12 months for women)
Key exclusion criteria (6 listed)
- meet full DSM-IV criteria for alcohol dependence in the past 12 months
- meet criteria for other current psychoactive substance abuse or dependence (excluding nicotine dependence and alcohol abuse) in the past 12 months [this would also exclude individuals with lifetime substance dependence who continue to have some abuse/dependence symptoms in the past 12 months]
- meet criteria for current dysthymia, major depression, or manic episode [past month]
- are currently psychotic [past 12 months] or suicidal [suicidal ideation or intent in the past month]
- have an unstable medical condition that would suggest caution in the use of the nicotine patch (e.g., unstable angina pectoris, arrhythmia, recent congestive heart failure)
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 |
|---|---|---|
| Standard treatment plus brief alcohol interventionStandard smoking cessation treatment with nicotine patch plus a brief alcohol-focused intervention | Behavioural | ST-BI |
| Standard treatment (ST)Behavioral smoking cessation counseling and nicotine patch. | Other | Standard treatment (ST) |
Primary outcome
Smoking Abstinence at 26 Weeks
Time frame: 26 weeks
7 days of smoking abstinence confirmed biochemically at 26 week post quit attempt
Smoking Abstinence at 16 Weeks
Time frame: 16 weeks
7 days of smoking abstinence confirmed biochemically at 16 weeks
Smoking Abstinence at 8 Weeks
Time frame: 8 weeks
7 days of smoking abstinence confirmed biochemically at 8 weeks
Smoking Abstinence at 2 Weeks
Time frame: 2 weeks
7 days of smoking abstinence confirmed biochemically at 2 weeks
1 secondary outcome
Alcohol Drinks Consumed Per Week Over a 2-week Period
Time frame: At 2, 8, 16, and 26-week follow-ups
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 18837602Kahler CW, Metrik J, LaChance HR, Ramsey SE, Abrams DB, Monti PM, Brown RA. Addressing heavy drinking in smoking cessation treatment: a randomized clinical trial. J Consult Clin Psychol. 2008 Oct;76(5):852-62. doi: 10.1037/a0012717.
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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.
Christopher W Kahler, Ph.D. principal investigator
Brown University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Standard treatment plus brief alcohol intervention and Standard treatment (ST) in people with Tobacco Use Disorder, run by Brown University 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 6 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 26 Oct 2016. 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.
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 11 Jan 2010). 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 at 26 Weeks (time frame: 26 weeks). The study lists 4 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 NCT00107575, 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 26 Oct 2016.