Tobacco DependencePhase 3IBISNCT01350011
Tobacco Intervention in Buprenorphine Treatment
A Phase 3 study testing Innovative System in people with Tobacco Dependence, run by University of California, San Francisco at 1 site in United States.
Trial summary
Drug addiction treatment patients, including those in treatment for opioid dependence, have a high rate of tobacco dependence, especially cigarette smoking. The proposed study evaluates an Innovative System (IS) for the treatment of tobacco dependence in one group of opioid treatment patients, those in buprenorphine… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tobacco Dependence
- What is being tested?
- Innovative System
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 175 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2011to 1 Dec 2016
- Phase
- Phase 3
- 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
- All participants must smoke five or more cigarettes a day and be registered patients at Integrated Buprenorphine Intervention Services (IBIS) of the San Francisco Department of Public Health.
Who cannot join
- Participants with contraindications to NRT will be excluded. Thus, participants who have had a myocardial infarction within the last three months, or who have uncontrolled high blood pressure will be excluded. We will exclude pregnant or nursing women.
- Participants with contraindications to varenicline treatment will be included in the study but will not be eligible for varenicline treatment.
Trial locations and contacts
1 site in 1 country.
United States1 site
Behavioral Health Access Center
San Francisco, California, 94103
About this study
Official title: Extended Tobacco Dependence Intervention in Buprenorphine Treatment
Drug addiction treatment patients, including those in treatment for opioid dependence, have a high rate of tobacco dependence, especially cigarette smoking. The proposed study evaluates an Innovative System (IS) for the treatment of tobacco dependence in one group of opioid treatment patients, those in buprenorphine maintenance. The specific aims of the study are to test the efficacy and the cost effectiveness of the IS.
A secondary aim is obtain preliminary data about differences in use of non-nicotinic drugs between participants who achieve abstinence from cigarettes during the study, and those who do not.
Read the detailed description
This component is grounded in the past work of the Center. It continues the tradition of working with complex populations in new settings. However, it addresses the problem that shorter (standard or traditional tobacco dependence) interventions do not appear to work well in this population, and it tests a research-based alternative that has shown effectiveness in prior research. If the Innovative System (IS) that we propose is shown to be effective in this population, this line of research will offer the field a strategy to more effectively address tobacco dependence among persons with non-nicotinic drug abuse disorders. It is an extended treatment, and with appropriate adaptations, could become a continuing care intervention in a variety of health systems using a variety of health care personnel, including pharmacists, primary care physicians \& nurses.
Drug addiction treatment patients, including those in treatment for opioid dependence, have a high rate of tobacco dependence, especially cigarette smoking. The proposed study evaluates an Innovative System (IS) for the treatment of tobacco dependence in one group of opioid treatment patients, those in buprenorphine maintenance. The primary specific aims of the proposed study are to test four efficacy hypotheses and to study cost and cost effectiveness of the IS. We will test the following four hypotheses and explore one additional primary aim:
- We hypothesize that at months 12 and 18, participants in IS will attain higher biochemically verified cigarette abstinence rates than those in STC.
- We hypothesize that at months 6, 12, and 18, participants in IS will report more quit attempts and more stringent cigarette abstinence goals than participants in STC.
- We hypothesize that, in both treatment conditions, a higher number of cigarettes smoked at baseline and higher baseline Fagerström Test of Nicotine Dependence (FTND) score will predict a lower probability of abstinence at months 3, 6, 12, and 18.
- We hypothesize that, in both experimental conditions, participants with smaller Cotinine/3HC (COT/3HC) ratios will be more likely to be abstinent at months 3, 6, 12, and 18, than those with larger ratios.
- The final primary specific aim is to determine the cost of providing innovative smoking cessation treatment to opiate dependent individuals in buprenorphine treatment and to learn if the treatment is cost-effective, that is, if its benefits are sufficient to justify its cost. This aim reflects an ongoing and historical emphasis in this P50 center grant, that of obtaining cost and cost-effectiveness data, as well as efficacy data A secondary aim is to obtain preliminary data about differences in use of non-nicotinic drugs between participants who achieve abstinence from cigarettes during the study, and those who do not.
- Conditions
- Tobacco Dependence
- Being tested
- Innovative System, Standard Treatment Control (STC)
- Keywords
- Nicotine Replacement Therapy, Buprenorphine, Varenicline, Smoking Cessation, Addiction, The Innovative System (IS) Treatment, The Standard Treatment Control (STC)
- Medical subject headings
- Tobacco Use Disorder, Smoking Cessation, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Innovative SystemBehavioural
In IS, they will receive motivational counseling at months 3,6,12, and 18. If they decide to quit smoking they will be offered up to 10 sessions of behavioral counseling and access to NRT (nicotine patch and gum) If they relapse on NRT, they will be offered varenicline, if it is not contraindicated.
Standard Treatment Control (STC)Behavioural
Participants will receive self help information and referrals for counseling and for pharmacological treatment.
| Study group | Role | What they receive |
|---|---|---|
| Innovative System (IS) | Active comparator | The innovative intervention uses the treatment system to support motivational counseling treatment entrance and treatment utilization. It has two components, a Motivational Intervention component via Expert System Counseling, and a Treatment Component that incorporates both pharmacological and behavioral long-term components. An innovative aspect of the IS is the use of the pharmacist as an intervention agent, who queries participants on their readiness to quit smoking, encourages involvement in the motivational intervention and in treatment, and who, along with the counselors, is available to answer medication questions. Receives: Behavioral: Innovative System |
| Standard Treatment Control | Active comparator | After a baseline interview, patients in this condition will be given a packet of brochures on quitting, including descriptions of self-quitting and help-lines. Participants in this condition will continue to have access to their primary care providers, and through that system have access to pharmacotherapy for smoking cessation, if they wish to receive it. They will receive written instructions on how to approach their primary care provider about smoking cessation medication, and a written description of the medications used in smoking cessation and a list of those that are available to them through the public health system. At each assessment, patients will be queried about their use of these resources. Receives: Behavioral: Standard Treatment Control (STC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking Status
Smoking status is defined as "no cigarettes for the past 7 days."
Measured: 3, 6, 12, and 18 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2011 (estimated)
- Study start1 Apr 2011
- Primary completion1 Apr 2016
- Study completion1 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tobacco DependenceStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 175 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
- Sharon Hall, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01350011
- Sponsor's protocol ID
- P030871
- Other IDs
- P50DA009253
- Acronym
- IBIS
- Status last verified
- Nov 2018
- First submitted
- 5 May 2011
- Last updated
- 13 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hall SM, Humfleet GL, Gasper JJ, Delucchi KL, Hersh DF, Guydish JR. Cigarette Smoking Cessation Intervention for Buprenorphine Treatment Patients. Nicotine Tob Res. 2018 Apr 2;20(5):628-635. doi: 10.1093/ntr/ntx113.
PubMed 28549161
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extended Tobacco Dependence Intervention in Buprenorphine Treatment
- ClinicalTrials.gov ID
- NCT01350011
- Acronym / sponsor ID
- IBIS / P030871
- Conditions
- Tobacco Dependence
- Keywords
- Nicotine Replacement Therapy, Buprenorphine, Varenicline, Smoking Cessation, Addiction, The Innovative System (IS) Treatment, The Standard Treatment Control (STC)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 1 Apr 2011 (actual)
- Primary completion
- 1 Apr 2016 (actual)
- Study completion
- 1 Dec 2016 (actual)
- First posted
- 9 May 2011 (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.
Drug addiction treatment patients, including those in treatment for opioid dependence, have a high rate of tobacco dependence, especially cigarette smoking. The proposed study evaluates an Innovative System (IS) for the treatment of tobacco dependence in one group of opioid treatment patients, those in buprenorphine maintenance. The specific aims of the study are to test the efficacy and the cost effectiveness of the IS.
A secondary aim is obtain preliminary data about differences in use of non-nicotinic drugs between participants who achieve abstinence from cigarettes during the study, and those who do not.
Detailed description
This component is grounded in the past work of the Center. It continues the tradition of working with complex populations in new settings. However, it addresses the problem that shorter (standard or traditional tobacco dependence) interventions do not appear to work well in this population, and it tests a research-based alternative that has shown effectiveness in prior research. If the Innovative System (IS) that we propose is shown to be effective in this population, this line of research will offer the field a strategy to more effectively address tobacco dependence among persons with non-nicotinic drug abuse disorders. It is an extended treatment, and with appropriate adaptations, could become a continuing care intervention in a variety of health systems using a variety of health care personnel, including pharmacists, primary care physicians \& nurses.
Drug addiction treatment patients, including those in treatment for opioid dependence, have a high rate of tobacco dependence, especially cigarette smoking. The proposed study evaluates an Innovative System (IS) for the treatment of tobacco dependence in one group of opioid treatment patients, those in buprenorphine maintenance. The primary specific aims of the proposed study are to test four efficacy hypotheses and to study cost and cost effectiveness of the IS. We will test the following four hypotheses and explore one additional primary aim:
- We hypothesize that at months 12 and 18, participants in IS will attain higher biochemically verified cigarette abstinence rates than those in STC.
- We hypothesize that at months 6, 12, and 18, participants in IS will report more quit attempts and more stringent cigarette abstinence goals than participants in STC.
- We hypothesize that, in both treatment conditions, a higher number of cigarettes smoked at baseline and higher baseline Fagerström Test of Nicotine Dependence (FTND) score will predict a lower probability of abstinence at months 3, 6, 12, and 18.
- We hypothesize that, in both experimental conditions, participants with smaller Cotinine/3HC (COT/3HC) ratios will be more likely to be abstinent at months 3, 6, 12, and 18, than those with larger ratios.
- The final primary specific aim is to determine the cost of providing innovative smoking cessation treatment to opiate dependent individuals in buprenorphine treatment and to learn if the treatment is cost-effective, that is, if its benefits are sufficient to justify its cost. This aim reflects an ongoing and historical emphasis in this P50 center grant, that of obtaining cost and cost-effectiveness data, as well as efficacy data A secondary aim is to obtain preliminary data about differences in use of non-nicotinic drugs between participants who achieve abstinence from cigarettes during the study, and those who do not.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Innovative System (IS) | Active comparator | Behavioral: Innovative SystemThe innovative intervention uses the treatment system to support motivational counseling treatment entrance and treatment utilization. It has two components, a Motivational Intervention component via Expert System Counseling, and a Treatment Component that incorporates both pharmacological and behavioral long-term components. An innovative aspect of the IS is the use of the pharmacist as an intervention agent, who queries participants on their readiness to quit smoking, encourages involvement in the motivational intervention and in treatment, and who, along with the counselors, is available to answer medication questions. |
| Standard Treatment Control | Active comparator | Behavioral: Standard Treatment Control (STC)After a baseline interview, patients in this condition will be given a packet of brochures on quitting, including descriptions of self-quitting and help-lines. Participants in this condition will continue to have access to their primary care providers, and through that system have access to pharmacotherapy for smoking cessation, if they wish to receive it. They will receive written instructions on how to approach their primary care provider about smoking cessation medication, and a written description of the medications used in smoking cessation and a list of those that are available to them through the public health system. At each assessment, patients will be queried about their use of these resources. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All participants must smoke five or more cigarettes a day and be registered patients at Integrated Buprenorphine Intervention Services (IBIS) of the San Francisco Department of Public Health.
Key exclusion criteria (2 listed)
- Participants with contraindications to NRT will be excluded. Thus, participants who have had a myocardial infarction within the last three months, or who have uncontrolled high blood pressure will be excluded. We will exclude pregnant or nursing women.
- Participants with contraindications to varenicline treatment will be included in the study but will not be eligible for varenicline treatment.
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 |
|---|---|---|
| Innovative SystemIn IS, they will receive motivational counseling at months 3,6,12, and 18. If they decide to quit smoking they will be offered up to 10 sessions of behavioral counseling and access to NRT (nicotine patch and gum) If they relapse on NRT, they will be offered varenicline, if it is not contraindicated. | Behavioural | Innovative System (IS) |
| Standard Treatment Control (STC)Participants will receive self help information and referrals for counseling and for pharmacological treatment. | Behavioural | Standard Treatment Control |
Primary outcome
Smoking Status
Time frame: 3, 6, 12, and 18 Months
Smoking status is defined as "no cigarettes for the past 7 days."
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 13 Nov 2018.
- Derived from this study: PubMed 28549161Hall SM, Humfleet GL, Gasper JJ, Delucchi KL, Hersh DF, Guydish JR. Cigarette Smoking Cessation Intervention for Buprenorphine Treatment Patients. Nicotine Tob Res. 2018 Apr 2;20(5):628-635. doi: 10.1093/ntr/ntx113.
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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.
Sharon Hall, PhD 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 Phase 3 study testing Innovative System in people with Tobacco 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 1 inclusion and 2 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 13 Nov 2018. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Smoking Status (time frame: 3, 6, 12, and 18 Months). 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 NCT01350011, 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 13 Nov 2018.