Smoking CessationNCT03068611
Development and Pilot Testing of a Multimodal Web-based Program to Address Heavy Drinking During Smoking Cessation
A study testing Standard Web-based Smoking Cessation and Alcohol-focused Web-Based Smoking Cessation in people with Smoking Cessation and Alcohol Drinking, run by Brown University at 1 site in United States.
Trial summary
The overall objective of this project is to develop and pilot-test a web-based smoking cessation program that specifically addresses heavy drinking (HD). The project builds upon a well-established, free evidence-based smoking cessation website, BecomeAnEX.org ("EX"), which is supported by Truth Initiative, a national… 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, Alcohol Drinking
- What is being tested?
- Standard Web-based Smoking Cessation and Alcohol-focused Web-Based Smoking Cessation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- 1 siteUnited States
- Study dates
- 11 May 2017to 30 Apr 2018
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- current daily smoking of at least one cigarette per day
- meeting NIAAA criteria for past month heavy or at-risk drinking (for women: drinking 8+ drinks per week or consuming 4+ drinks on one occasion at least once in the past month; for men: drinking 15+ drinks per week or consuming 5+ drinks on one occasion at least once in the past month)
- age 18 or older
- willingness to provide contact and mailing information following consent
Who cannot join
- 1. history of severe alcohol withdrawal as indicated by past alcohol-induced seizures or delirium tremens;
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Alcohol and Addiction Studies, Brown University
Providence, Rhode Island, 02912
About this study
The overall objective of this project is to develop and pilot-test a web-based smoking cessation program that specifically addresses heavy drinking (HD). The project builds upon a well-established, free evidence-based smoking cessation website, BecomeAnEX.org ("EX"), which is supported by Truth Initiative, a national non-profit public health organization, and its research arm, the Schroeder Institute. Investigators will develop an alternative version of BecomenAnEX that will include detailed content on alcohol's relation to smoking relapse, health effects of alcohol (including moderate drinking recommendations) along with related worksheets, feedback materials, and links to resources for drinking. Once a version of BecomeAnEX is developed that specifically addresses HD (called EX-HD), the investigators will conduct a one-arm open pilot of the site with 30 HD smokers recruited from newly registered BecomeAnEX users. The study will gather participant feedback on the site as well as site use metrics (e.g., number of logins, number of pages viewed, use of interactive components) and will revise EX-HD in response to this feedback in preparation for Stage 1b work. Stage 1b will use the updated EX-HD version to run a small scale randomized clinical trial where 120 participants will be randomly assigned to the standard version of BecomeAnEX or to EX-HD.
- Conditions
- Smoking Cessation, Alcohol Drinking
- Being tested
- Standard Web-based Smoking Cessation, Alcohol-focused Web-Based Smoking Cessation
- Medical subject headings
- Smoking Cessation, Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Web-based Smoking CessationBehavioural
A website and text messaging program that is publicly available through BecomeAnEX.com. Participants have access to the website whenever they wish.
Alcohol-focused Web-Based Smoking CessationBehavioural
A website and text messaging program that is publicly available through BecomeAnEX.com. Participants have access to the website whenever they wish.
| Study group | Role | What they receive |
|---|---|---|
| Standard Web-based Smoking Cessation | Active comparator | A website and text messaging program that is publicly available through BecomeAnEX.com. Participants have access to the website whenever they wish. Receives: Behavioral: Standard Web-based Smoking Cessation |
| Alcohol-focused Web-Based Smoking Cessation | Experimental | A modified version of the website and text messaging program that is publicly available through BecomeAnEX.com. This version includes specific information and feedback on alcohol use, allows participants to consider benefits of changing drinking, plans for changing drinking, and strategies. Participants have access to the website whenever they wish. Receives: Behavioral: Alcohol-focused Web-Based Smoking Cessation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Reported 7-day Point-prevalence Smoking Abstinence at 1 Month
Self-report abstinence from smoking
Measured: 1 month after enrollment
Number of Participants Who Reported 7-day Point-prevalence Smoking Abstinence at 6 Months
Self-report abstinence from smoking
Measured: 6 months after enrollment
Number of Heavy Drinking Days at 1 Month
Self reported number of days (in the past 30 days) drinking 4+/5+ drinks for women/men
Measured: 1 month after enrollment
Number of Heavy Drinking Days at 6 Months
Self reported number of days (in the past 30 days) drinking 4+/5+ drinks for women/men
Measured: 6 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2017
- Study start11 May 2017
- Primary completion1 Apr 2018
- Study completion30 Apr 2018
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 Smoking CessationStudies of the same condition, open and under way.
- 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
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Collaborators
- Truth Initiative
- Responsible party
- Principal investigator, Christopher W. Kahler, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03068611
- Sponsor's protocol ID
- R34AA024593
- Status last verified
- Sep 2019
- First submitted
- 23 Feb 2017
- Last updated
- 7 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kahler CW, Cohn AM, Costantino C, Toll BA, Spillane NS, Graham AL. A Digital Smoking Cessation Program for Heavy Drinkers: Pilot Randomized Controlled Trial. JMIR Form Res. 2020 Jun 8;4(6):e7570. doi: 10.2196/formative.7570.
PubMed 32348286
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Pilot Testing of a Multimodal Web-based Program to Address Heavy Drinking During Smoking Cessation
- ClinicalTrials.gov ID
- NCT03068611
- Acronym / sponsor ID
- R34AA024593
- Conditions
- Smoking Cessation, Alcohol Drinking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Collaborators
- Truth Initiative
- Study start
- 11 May 2017 (actual)
- Primary completion
- 1 Apr 2018 (actual)
- Study completion
- 30 Apr 2018 (actual)
- First posted
- 3 Mar 2017 (actual)
- Results
- Posted 7 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall objective of this project is to develop and pilot-test a web-based smoking cessation program that specifically addresses heavy drinking (HD). The project builds upon a well-established, free evidence-based smoking cessation website, BecomeAnEX.org ("EX"), which is supported by Truth Initiative, a national non-profit public health organization, and its research arm, the Schroeder Institute. Investigators will develop an alternative version of BecomenAnEX that will include detailed content on alcohol's relation to smoking relapse, health effects of alcohol (including moderate drinking recommendations) along with related worksheets, feedback materials, and links to resources for drinking. Once a version of BecomeAnEX is developed that specifically addresses HD (called EX-HD), the investigators will conduct a one-arm open pilot of the site with 30 HD smokers recruited from newly registered BecomeAnEX users. The study will gather participant feedback on the site as well as site use metrics (e.g., number of logins, number of pages viewed, use of interactive components) and will revise EX-HD in response to this feedback in preparation for Stage 1b work. Stage 1b will use the updated EX-HD version to run a small scale randomized clinical trial where 120 participants will be randomly assigned to the standard version of BecomeAnEX or to EX-HD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Web-based Smoking Cessation | Active comparator | Behavioral: Standard Web-based Smoking CessationA website and text messaging program that is publicly available through BecomeAnEX.com. Participants have access to the website whenever they wish. |
| Alcohol-focused Web-Based Smoking Cessation | Experimental | Behavioral: Alcohol-focused Web-Based Smoking CessationA modified version of the website and text messaging program that is publicly available through BecomeAnEX.com. This version includes specific information and feedback on alcohol use, allows participants to consider benefits of changing drinking, plans for changing drinking, and strategies. Participants have access to the website whenever they wish. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- current daily smoking of at least one cigarette per day
- meeting NIAAA criteria for past month heavy or at-risk drinking (for women: drinking 8+ drinks per week or consuming 4+ drinks on one occasion at least once in the past month; for men: drinking 15+ drinks per week or consuming 5+ drinks on one occasion at least once in the past month)
- age 18 or older
- willingness to provide contact and mailing information following consent
Key exclusion criteria (1 listed)
- 1. history of severe alcohol withdrawal as indicated by past alcohol-induced seizures or delirium tremens;
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 Web-based Smoking CessationA website and text messaging program that is publicly available through BecomeAnEX.com. Participants have access to the website whenever they wish. | Behavioural | Standard Web-based Smoking Cessation |
| Alcohol-focused Web-Based Smoking CessationA website and text messaging program that is publicly available through BecomeAnEX.com. Participants have access to the website whenever they wish. | Behavioural | Alcohol-focused Web-Based Smoking Cessation |
Primary outcome
Number of Participants Who Reported 7-day Point-prevalence Smoking Abstinence at 1 Month
Time frame: 1 month after enrollment
Self-report abstinence from smoking
Number of Participants Who Reported 7-day Point-prevalence Smoking Abstinence at 6 Months
Time frame: 6 months after enrollment
Self-report abstinence from smoking
Number of Heavy Drinking Days at 1 Month
Time frame: 1 month after enrollment
Self reported number of days (in the past 30 days) drinking 4+/5+ drinks for women/men
Number of Heavy Drinking Days at 6 Months
Time frame: 6 months after enrollment
Self reported number of days (in the past 30 days) drinking 4+/5+ drinks for women/men
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32348286Kahler CW, Cohn AM, Costantino C, Toll BA, Spillane NS, Graham AL. A Digital Smoking Cessation Program for Heavy Drinkers: Pilot Randomized Controlled Trial. JMIR Form Res. 2020 Jun 8;4(6):e7570. doi: 10.2196/formative.7570.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Web-based Smoking Cessation and Alcohol-focused Web-Based Smoking Cessation in people with Smoking Cessation and Alcohol Drinking, 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 4 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: finished, as of the sponsor's last update on 7 Oct 2019. 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?
Yes. Results are posted in the registry (first posted 7 Oct 2019). 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?
Number of Participants Who Reported 7-day Point-prevalence Smoking Abstinence at 1 Month (time frame: 1 month after enrollment). 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 NCT03068611, 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 7 Oct 2019.