A Smoking Intervention Study Using Scheduled Gradual Reduction With Varenicline to Help With Cessation

Nicotine Addiction Clinical Trial

Official title:

A Combination of Scheduled Reduced Smoking With Varenicline to Enhance Cessation

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01772641
• Other study ID #: GCO 10-0879
• Secondary ID: 5R34DA031327-02
• Status: Terminated
• Phase: Phase 4
• First received: January 17, 2013
• Last updated: March 14, 2016
• Start date: December 2012
• Est. completion date: January 2014

Study information

• Verified date: March 2016
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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). 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.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 32
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Current illicit substance use

• Other tobacco use (e.g., cigar, pipe)

• History of psychosis

• Past or current cardiovascular disease

• Impaired renal functioning

• Pregnancy

• Nursing

• Current treatment for smoking cessation

• Clinically significant depressive symptoms (CES-D > 16)

• Current suicidal ideation

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Nicotine Addiction

Intervention

Other:
• Scheduled Gradual Reduction + Varenicline
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 Drug
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 + Varenicline
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 Drug
Participants will receive informational pamphlets with advice about quitting smoking. Additionally, they will take placebo pills matching the schedule of the VN group.

Locations

Country	Name	City	State
United States	Icahn School of Medicine at Mount Sinai	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of Prolonged Abstinence	Prolonged Abstinence from 12 weeks post-quit as compared to 4 weeks post-quit	up to12 weeks post-quit	No
Secondary	Comparison of Continuous Abstinence	Continuous Abstinence as compared from 30 days post-quit to 30 days post end-of-treatment	30 days post-quit and 30 days post end-of-treatment	No
Secondary	Comparison of Survival	Survival as compared from 30 days post-quit to 30 days post end-of-treatment	30 days post-quit and 30 days post end-of-treatment	No