Nicotine DependencePhase 3NCT01162239
Maintaining Nonsmoking
A Phase 3 study testing Varenicline, Initial Individual counseling and Check-ins with medical staff in people with Nicotine Dependence, run by University of California, San Francisco at 1 site in United States.
Trial summary
The research is based on a chronic disorder model of cigarette smoking which suggests that long-term treatment targeted to prevent relapse may be useful. Based on this model, the investigators have developed a relapse prevention treatment to intervene on five areas important in relapse prevention, including… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nicotine Dependence
- What is being tested?
- Varenicline, Initial Individual counseling and Check-ins with medical staff
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 1 siteUnited States
- Study dates
- May 2010to Jun 2016
- Phase
- Phase 3
- 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
- At least 18 years of age
- Must be smoking 5 or more cigarettes per day
Who cannot join
- Previous history of bipolar/manic-depressive disorder
- Current diagnosis of schizophrenia
- Acute life threatening diseases
- Evidence of alcohol or other drug abuse so severe that the patient is judged to be potentially unable to comply with the protocol
- Pregnancy or lactation
- Individuals with out of normal range blood pressure, active angina, valve disease, valve replacement, active cardiomyopathies, myocardial infarction or Coronary artery bypass grafting (CABG) within one year, and Congestive heart failure (CHF)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Francisco
San Francisco, California, 94143
About this study
The research is based on a chronic disorder model of cigarette smoking which suggests that long-term treatment targeted to prevent relapse may be useful. Based on this model, the investigators have developed a relapse prevention treatment to intervene on five areas important in relapse prevention, including fluctuating motivation, depression, withdrawal, weight gain, and social support. This treatment protocol has produced high long-term abstinence rates when implemented in a clinical research setting. The current study will evaluate the treatment model when implemented in a medical outpatient setting.
Read the detailed description
This study will test a series of hypotheses comparing the efficacy of the relapse prevention treatment to other extended treatments. All participants will be assessed at baseline on demographics, smoking behaviors, nicotine dependence, depression, alcohol and other drug history and problems, mood disturbance, treatment support, stress, health status, and motivation for change. Participants will be randomly assigned to one of four treatment conditions. All participants will receive 12 weeks of combined pharmacological treatment (varenicline) and behavioral treatment (five individual counseling sessions). Following this brief treatment, participants will be randomly assigned to one of four treatment protocols
- Monthly Brief Contact or
- Extended Non-Specific Behavioral Treatment or
- Extended Relapse Prevention Treatment or
- Extended Relapse Prevention Treatment + availability of varenicline treatment.
Each extended treatment protocol is 40 weeks in duration following the initial 12 weeks of treatment.
All participants will be assessed at weeks 12, 24, 52, 64, and 104, on smoking as well as other psychometric measures.
- Conditions
- Nicotine Dependence
- Being tested
- Varenicline, Initial Individual counseling, Check-ins with medical staff, Extended Individual Counseling - Health Model, Extended Individual Counseling - Relapse Prevention Model
- Keywords
- Smoking, Tobacco, Nicotine, Smoking cessation
- Medical subject headings
- Tobacco Use Disorder, Smoking, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VareniclineDrug
Also called Chantix
All participants will receive 12 weeks of varenicline treatment at standard dosage of 1 mg bid. Participants in the Extended Relapse Prevention plus varenicline will receive varenicline for up to 40 additional weeks.
Initial Individual counselingBehavioural
Five 90 minute individual counseling sessions to occur during the first 12 weeks of initial treatment.
Check-ins with medical staffBehavioural
Monthly brief (10-15 minutes) meetings with medical staff.
Extended Individual Counseling - Health ModelBehavioural
Monthly counseling sessions across a nine month period with content based on a health education model. Each session is 30-45 minutes in duration.
Extended Individual Counseling - Relapse Prevention ModelBehavioural
Eleven individual counseling sessions across a nine month period with content based on a relapse prevention model. Each session is 30-45 minutes in duration.
| Study group | Role | What they receive |
|---|---|---|
| Extended Brief Contact | Experimental | Following standard brief treatment, participants have monthly meetings with medical staff. Receives: Drug: Varenicline; Behavioral: Initial Individual counseling; Behavioral: Check-ins with medical staff |
| Extended Health Education | Experimental | Following standard treatment, participants receive monthly counseling with content based on a health education model. Receives: Drug: Varenicline; Behavioral: Initial Individual counseling; Behavioral: Extended Individual Counseling - Health Model |
| Extended Relapse Prevention plus varenicline | Experimental | Following standard treatment, participants receive monthly counseling with content based on a relapse prevention model plus access to ongoing medication treatment with varenicline. Receives: Drug: Varenicline; Behavioral: Initial Individual counseling; Behavioral: Extended Individual Counseling - Relapse Prevention Model |
| Extended Relapse Prevention | Experimental | Following standard treatment, participants receive monthly counseling with content based on a relapse prevention model. Receives: Drug: Varenicline; Behavioral: Initial Individual counseling; Behavioral: Extended Individual Counseling - Relapse Prevention Model |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Reported 7-day Point Prevalence Abstinence at Week 12
Point prevalent abstinence is defined as biochemically verified (confirmed carbon dioxide (CO) < 8 parts per million (ppm)) self-reported abstinence from smoking cigarettes in the past 7 days. Smoking status was then categorized as either Abstinent or Not Abstinent.
Measured: 12 weeks following treatment initiation
Number of Participants With Reported 7-day Point Prevalence Abstinence at Week 24
Point prevalent abstinence is defined as biochemically verified (confirmed carbon dioxide (CO) < 8 ppm) self-reported abstinence from smoking cigarettes in the past 7 days. Smoking status was then categorized as either Abstinent or Not Abstinent.
Measured: 24 weeks following treatment initiation
Number of Participants With Reported 7-day Point Prevalence Abstinence at Week 52
Point prevalent abstinence is defined as biochemically verified (confirmed carbon dioxide (CO) < 8 ppm) self-reported abstinence from smoking cigarettes in the past 7 days. Smoking status was then categorized as either Abstinent or Not Abstinent.
Measured: 52 weeks following treatment initiation
Number of Participants With Reported 7-day Point Prevalence Abstinence at Follow-up Week 64
Point prevalent abstinence is defined as biochemically verified (confirmed carbon dioxide (CO) < 8 ppm) self-reported abstinence from smoking cigarettes in the past 7 days. Smoking status was then categorized as either Abstinent or Not Abstinent.
Measured: 64 weeks following treatment initiation
Number of Participants With Reported 7-day Point Prevalence Abstinence at Follow-up Week 104
Point prevalent abstinence is defined as biochemically verified (confirmed carbon dioxide (CO) < 8 ppm) self-reported abstinence from smoking cigarettes in the past 7 days. Smoking status was then categorized as either Abstinent or Not Abstinent.
Measured: 104 weeks following treatment initiation
Secondary outcomes (2)
Comparison of Combined Extended vs Brief Treatment at Week 24
The three extended treatment programs were combined and compared to the Brief treatment, with extended treatments expected to produce significant higher CO corrected abstinence rates overall. Comparisons will be tested using Chi-Square analysis.
Measured: 24 weeks following treatment initiation
Comparison of Combined Extended vs Brief Treatment at Week 52
The three extended treatment programs were combined and compared to the Brief treatment, with extended treatments expected to produce significant higher CO corrected abstinence rates overall. Comparisons will be tested using Chi-Square analysis.
Measured: 52 weeks following treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2010 (estimated)
- Study startMay 2010
- Primary completionJun 2016
- Study completionJun 2016
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 Nicotine 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
- 216 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), Pfizer
- Responsible party
- Sponsor
- Investigators
- Gary Humfleet, Ph. D., Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01162239
- Sponsor's protocol ID
- DA002538
- Other IDs
- 2R01DA002538, 11633
- Status last verified
- Oct 2020
- First submitted
- 14 Jun 2010
- Last updated
- 12 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Livingstone-Banks J, Fanshawe TR, Thomas KH, Theodoulou A, Hajizadeh A, Hartman L, Lindson N. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2023 May 5;5(5):CD006103. doi: 10.1002/14651858.CD006103.pub8.
PubMed 37142273
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maintaining Nonsmoking
- ClinicalTrials.gov ID
- NCT01162239
- Acronym / sponsor ID
- DA002538
- Conditions
- Nicotine Dependence
- Keywords
- Smoking, Tobacco, Nicotine, Smoking cessation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), Pfizer
- Study start
- May 2010 (actual)
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 14 Jul 2010 (estimated)
- Results
- Posted 12 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The research is based on a chronic disorder model of cigarette smoking which suggests that long-term treatment targeted to prevent relapse may be useful. Based on this model, the investigators have developed a relapse prevention treatment to intervene on five areas important in relapse prevention, including fluctuating motivation, depression, withdrawal, weight gain, and social support. This treatment protocol has produced high long-term abstinence rates when implemented in a clinical research setting. The current study will evaluate the treatment model when implemented in a medical outpatient setting.
Detailed description
This study will test a series of hypotheses comparing the efficacy of the relapse prevention treatment to other extended treatments. All participants will be assessed at baseline on demographics, smoking behaviors, nicotine dependence, depression, alcohol and other drug history and problems, mood disturbance, treatment support, stress, health status, and motivation for change. Participants will be randomly assigned to one of four treatment conditions. All participants will receive 12 weeks of combined pharmacological treatment (varenicline) and behavioral treatment (five individual counseling sessions). Following this brief treatment, participants will be randomly assigned to one of four treatment protocols
- Monthly Brief Contact or
- Extended Non-Specific Behavioral Treatment or
- Extended Relapse Prevention Treatment or
- Extended Relapse Prevention Treatment + availability of varenicline treatment.
Each extended treatment protocol is 40 weeks in duration following the initial 12 weeks of treatment.
All participants will be assessed at weeks 12, 24, 52, 64, and 104, on smoking as well as other psychometric measures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Extended Brief Contact | Experimental | Drug: Varenicline, Behavioral: Initial Individual counseling, Behavioral: Check-ins with medical staffFollowing standard brief treatment, participants have monthly meetings with medical staff. |
| Extended Health Education | Experimental | Drug: Varenicline, Behavioral: Initial Individual counseling, Behavioral: Extended Individual Counseling - Health ModelFollowing standard treatment, participants receive monthly counseling with content based on a health education model. |
| Extended Relapse Prevention plus varenicline | Experimental | Drug: Varenicline, Behavioral: Initial Individual counseling, Behavioral: Extended Individual Counseling - Relapse Prevention ModelFollowing standard treatment, participants receive monthly counseling with content based on a relapse prevention model plus access to ongoing medication treatment with varenicline. |
| Extended Relapse Prevention | Experimental | Drug: Varenicline, Behavioral: Initial Individual counseling, Behavioral: Extended Individual Counseling - Relapse Prevention ModelFollowing standard treatment, participants receive monthly counseling with content based on a relapse prevention model. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- At least 18 years of age
- Must be smoking 5 or more cigarettes per day
Key exclusion criteria (6 listed)
- Previous history of bipolar/manic-depressive disorder
- Current diagnosis of schizophrenia
- Acute life threatening diseases
- Evidence of alcohol or other drug abuse so severe that the patient is judged to be potentially unable to comply with the protocol
- Pregnancy or lactation
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 |
|---|---|---|
| VareniclineAlso: ChantixAll participants will receive 12 weeks of varenicline treatment at standard dosage of 1 mg bid. Participants in the Extended Relapse Prevention plus varenicline will receive varenicline for up to 40 additional weeks. | Drug | Extended Brief Contact, Extended Health Education, Extended Relapse Prevention, Extended Relapse Prevention plus varenicline |
| Initial Individual counselingFive 90 minute individual counseling sessions to occur during the first 12 weeks of initial treatment. | Behavioural | Extended Brief Contact, Extended Health Education, Extended Relapse Prevention, Extended Relapse Prevention plus varenicline |
| Check-ins with medical staffMonthly brief (10-15 minutes) meetings with medical staff. | Behavioural | Extended Brief Contact |
| Extended Individual Counseling - Health ModelMonthly counseling sessions across a nine month period with content based on a health education model. Each session is 30-45 minutes in duration. | Behavioural | Extended Health Education |
| Extended Individual Counseling - Relapse Prevention ModelEleven individual counseling sessions across a nine month period with content based on a relapse prevention model. Each session is 30-45 minutes in duration. | Behavioural | Extended Relapse Prevention, Extended Relapse Prevention plus varenicline |
Primary outcome
Number of Participants With Reported 7-day Point Prevalence Abstinence at Week 12
Time frame: 12 weeks following treatment initiation
Point prevalent abstinence is defined as biochemically verified (confirmed carbon dioxide (CO) < 8 parts per million (ppm)) self-reported abstinence from smoking cigarettes in the past 7 days. Smoking status was then categorized as either Abstinent or Not Abstinent.
Number of Participants With Reported 7-day Point Prevalence Abstinence at Week 24
Time frame: 24 weeks following treatment initiation
Point prevalent abstinence is defined as biochemically verified (confirmed carbon dioxide (CO) < 8 ppm) self-reported abstinence from smoking cigarettes in the past 7 days. Smoking status was then categorized as either Abstinent or Not Abstinent.
Number of Participants With Reported 7-day Point Prevalence Abstinence at Week 52
Time frame: 52 weeks following treatment initiation
Point prevalent abstinence is defined as biochemically verified (confirmed carbon dioxide (CO) < 8 ppm) self-reported abstinence from smoking cigarettes in the past 7 days. Smoking status was then categorized as either Abstinent or Not Abstinent.
Number of Participants With Reported 7-day Point Prevalence Abstinence at Follow-up Week 64
Time frame: 64 weeks following treatment initiation
Point prevalent abstinence is defined as biochemically verified (confirmed carbon dioxide (CO) < 8 ppm) self-reported abstinence from smoking cigarettes in the past 7 days. Smoking status was then categorized as either Abstinent or Not Abstinent.
Number of Participants With Reported 7-day Point Prevalence Abstinence at Follow-up Week 104
Time frame: 104 weeks following treatment initiation
Point prevalent abstinence is defined as biochemically verified (confirmed carbon dioxide (CO) < 8 ppm) self-reported abstinence from smoking cigarettes in the past 7 days. Smoking status was then categorized as either Abstinent or Not Abstinent.
2 secondary outcomes
Comparison of Combined Extended vs Brief Treatment at Week 24
Time frame: 24 weeks following treatment initiation
Comparison of Combined Extended vs Brief Treatment at Week 52
Time frame: 52 weeks following treatment initiation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37142273Livingstone-Banks J, Fanshawe TR, Thomas KH, Theodoulou A, Hajizadeh A, Hartman L, Lindson N. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2023 May 5;5(5):CD006103. doi: 10.1002/14651858.CD006103.pub8.
- 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.
Gary Humfleet, 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 Phase 3 study testing Varenicline, Initial Individual counseling and Check-ins with medical staff in people with Nicotine 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 2 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 12 Nov 2020. 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?
Yes. Results are posted in the registry (first posted 12 Nov 2020). 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 With Reported 7-day Point Prevalence Abstinence at Week 12 (time frame: 12 weeks following treatment initiation). The study lists 5 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 NCT01162239, 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 12 Nov 2020.