Nicotine AddictionPhase 4NCT01772641
A Smoking Intervention Study Using Scheduled Gradual Reduction With Varenicline to Help With Cessation
A Phase 4 study testing Scheduled Gradual Reduction + Varenicline and Basic Advice + Varenicline in people with Nicotine Addiction, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
This study has three main aims. Aim 1: To provide initial data on the efficacy of combined Scheduled Gradual Reduction (SGR) and Varenicline (VN) for smoking cessation, by assessing abstinence and levels of smoking at 2 time points (4 and 12 weeks post quit). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nicotine Addiction
- What is being tested?
- Scheduled Gradual Reduction + Varenicline and Basic Advice + Varenicline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2012to Jan 2014
- Phase
- Phase 4
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 cigarette smoker
- Averages at least 10 cigarettes/day for 5 or more years
- DSM-IV diagnosis of Nicotine Dependence
- Breath carbon monoxide > 6 ppm
- Motivated to quit: score > 8 on Contemplation Ladder
- Age > 18 years
Who cannot join
- Current illicit substance use
- Other tobacco use (e.g., cigar, pipe)
- History of psychosis
- Past or current cardiovascular disease
- Impaired renal functioning
- Pregnancy
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- Nursing
- Current treatment for smoking cessation
- Clinically significant depressive symptoms (CES-D > 16)
- Current suicidal ideation
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: A Combination of Scheduled Reduced Smoking With Varenicline to Enhance Cessation
This study has three main aims. Aim 1: To provide initial data on the efficacy of combined Scheduled Gradual Reduction (SGR) and Varenicline (VN) for smoking cessation, by assessing abstinence and levels of smoking at 2 time points (4 and 12 weeks post quit). Aim 2: To explore the possibility that SGR+VN will be particularly efficacious among smokers with higher background levels of Cue Reactivity (CR), as assessed at the start of the study, using a classic experimental smoking CR paradigm. Aim 3: To explore possible mechanisms underlying the effects of SGR+VN, by assessing potential mediators (i.e., self-efficacy, cue-induced cravings) of treatment effects.
Read the detailed description
Smoking remains an intransigent public health concern. There is ample evidence that non-pharmacological factors, such as environmental triggers (e.g., sight or smell of a cigarette), can give rise to strong classically-conditioned urges to smoke (termed 'cue-reactivity' [CR]), and that exposure to smoking cues can contribute to cessation failure. One promising intervention that may address CR is scheduled smoking with gradual reduction (SGR). Under SGR, individuals smoke only at fixed intervals, and over several weeks, systematically decrease their cigarettes consumed each day. The approach is postulated to: 1) provide 'practice' coping with environmentally-triggered cravings that occur during the inter-cigarette intervals, yielding increased self-efficacy to quit, and 2) weaken the associations between cues and smoking. Accumulating evidence has also shown that the smoking cessation drug, varenicline (VN), substantially ameliorates cravings and enhances cessation, significantly outperforming other drugs. Interestingly, recent animal research suggests that VN may operate at least partially by dampening conditioned drug cravings. A combination therapy consisting of SGR+VN might thus lead to significantly enhanced cessation, simultaneously attacking cravings using both pharmacological and non-pharmacological approaches. Because the beneficial effects of SGR and VN may be at least partially due to enhanced management of conditioned cravings, it is possible that that they will be particularly efficacious for smokers with high levels of CR. Using both laboratory experimental techniques and a prospective intervention design in this R34 application, we propose to provide initial data to: 1) test the hypothesis that a combination of SGR+VN will enhance cessation, 2) explore the possibility that SGR and VN might be particularly efficacious among smokers with higher levels of CR, and 3) explore potential mechanisms underlying treatment effects. Findings from this study would set the stage for larger efficacy and effectiveness trials of SGR alone and in conjunction with VN, as well as efforts to target SGR and/or VN toward the subgroups that would benefit the most (e.g., smokers with high levels of CR, carriers of specific smoking-related genotypes).
- Conditions
- Nicotine Addiction
- Being tested
- Scheduled Gradual Reduction + Varenicline, Scheduled Gradual Reduction + Placebo Drug, Basic Advice + Varenicline, Basic Advice + Placebo Drug
- Keywords
- cigarette, smoking, cessation, varenicline, scheduled reduction, craving
- Medical subject headings
- Tobacco Use Disorder, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scheduled Gradual Reduction + VareniclineOther
Participants will receive a four-week Scheduled Gradual Reduction (SGR) intervention in which participants cut down on the number of cigarettes smoked. This is done through a smoking schedule in which participants smoke a cigarette at given fixed and equal intervals throughout their waking day. Additionally, they will take 0.5 mg of Varenicline (VN) once a day for the first three days, then 0.5 mg twice a day for the next four days, and they will continue for 13 weeks at 1.0 mg twice per day.
Scheduled Gradual Reduction + Placebo DrugOther
Participants will receive a four-week Scheduled Gradual Reduction (SGR) intervention in which participants cut down on the number of cigarettes smoked. This is done through a smoking schedule in which participants smoke a cigarette at given fixed and equal intervals throughout their waking day. Additionally, they will take placebo pills matching the schedule of the VN group.
Basic Advice + VareniclineOther
Participants will receive informational pamphlets with advice about quitting smoking. Additionally, they will take 0.5 mg of Varenicline (VN) once a day for the first three days, then 0.5 mg twice a day for the next four days, and they will continue for 13 weeks at 1.0 mg twice per day.
Basic Advice + Placebo DrugOther
Participants will receive informational pamphlets with advice about quitting smoking. Additionally, they will take placebo pills matching the schedule of the VN group.
| Study group | Role | What they receive |
|---|---|---|
| Scheduled Gradual Reduction + Varenicline | Experimental | Participants will be given the behavioral intervention of Scheduled Gradual Reduction along with the smoking cessation drug, Varenicline. Receives: Other: Scheduled Gradual Reduction + Varenicline |
| Scheduled Gradual Reduction + Placebo Drug | Experimental | Participants will be given the behavioral intervention, SGR, along with a placebo drug matching the schedule of the VN group. Receives: Other: Scheduled Gradual Reduction + Placebo Drug |
| Basic Advice + Varenicline | Experimental | Participants will be given basic advice about quitting smoking along with the smoking cessation drug Varenicline Receives: Other: Basic Advice + Varenicline |
| Basic Advice + Placebo Drug | Placebo comparator | Participants will be given basic advice along with a placebo drug matching the schedule of the VN group. Receives: Other: Basic Advice + Placebo Drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of Prolonged Abstinence
Prolonged Abstinence from 12 weeks post-quit as compared to 4 weeks post-quit
Measured: up to12 weeks post-quit
Secondary outcomes (2)
Comparison of Continuous Abstinence
Continuous Abstinence as compared from 30 days post-quit to 30 days post end-of-treatment
Measured: 30 days post-quit and 30 days post end-of-treatment
Comparison of Survival
Survival as compared from 30 days post-quit to 30 days post end-of-treatment
Measured: 30 days post-quit and 30 days post end-of-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2013 (estimated)
- Study startDec 2012
- Primary completionJan 2014
- Study completionJan 2014
Why it stopped: difficulty recruiting and retaining participants
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 Nicotine AddictionStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Joel Erblich, Icahn School of Medicine at Mount Sinai
- Investigators
- Joel Erblich, Ph.D, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01772641
- Sponsor's protocol ID
- GCO 10-0879
- Other IDs
- 5R34DA031327-02
- Status last verified
- Mar 2016
- First submitted
- 17 Jan 2013
- Last updated
- 16 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
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