Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: An Effectiveness Trial of Maintenance Therapy for Nicotine Dependence
Brief Summary: The transdermal nicotine patch is the most widely used form of tobacco dependence treatment in the US and Europe, but most smokers are unable to successfully quit with this form of treatment. Failure to respond to this treatment may, to a large extent, be due to the use of nicotine patches for only 8 weeks, the recommended treatment duration. We have found in a controlled randomized clinical trial that using the nicotine patch for 24 weeks can increase quit rates significantly. We propose here a clinical trial to replicate and extend these results to a community setting in the real-world, using the same research design utilized in clinical trials to demonstrate the effectiveness of methadone maintenance therapy for opiate dependence. Specifically, 540 smokers will receive counseling and standard (8-weeks), extended (24-weeks), or maintenance (52 weeks) therapy with transdermal nicotine patches. The main outcome is biochemically-verified smoking cessation at week 52. The cost-effectiveness, safety, and mechanism of effect (e.g., promotion of recovery following a lapse) for maintenance therapy with transdermal nicotine will also be assessed. The study results may change how we treat nicotine dependence with transdermal nicotine.


Options:
A: Arm Label: varenicline; Type: ACTIVE_COMPARATOR; Interventions: Drug: Varenicline | Arm Label: Nicotine Patches only; Type: ACTIVE_COMPARATOR; Interventions: Drug: Nicotine patches | Arm Label: Nicotine Patches with Nicotine Inhaler; Type: ACTIVE_COMPARATOR; Interventions: Drug: Nicotine patches, Drug: Nicotine Inhaler | Arm Label: varenicline with bupropion; Type: ACTIVE_COMPARATOR; Interventions: Drug: Varenicline, Drug: Bupropion | Intervention Type: DRUG; Name: Varenicline; Assigned to Arm(s): varenicline, varenicline with bupropion | Intervention Type: DRUG; Name: Bupropion; Assigned to Arm(s): varenicline with bupropion | Intervention Type: DRUG; Name: Nicotine patches; Assigned to Arm(s): Nicotine Patches only, Nicotine Patches with Nicotine Inhaler | Intervention Type: DRUG; Name: Nicotine Inhaler; Assigned to Arm(s): Nicotine Patches with Nicotine Inhaler
B: Arm Label: 8 weeks transdermal nicotine; Type: ACTIVE_COMPARATOR; Interventions: Drug: Transdermal nicotine patch | Arm Label: 24 weeks transdermal nicotine; Type: ACTIVE_COMPARATOR; Interventions: Drug: Transdermal nicotine patch | Arm Label: 52 weeks transdermal nicotine; Type: EXPERIMENTAL; Interventions: Drug: Transdermal nicotine patch | Intervention Type: DRUG; Name: Transdermal nicotine patch; Assigned to Arm(s): 24 weeks transdermal nicotine, 52 weeks transdermal nicotine, 8 weeks transdermal nicotine
C: Intervention Type: BEHAVIORAL; Name: smoking cessation intervention; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: varenicline; Assigned to Arm(s): N/A | Intervention Type: OTHER; Name: counseling intervention; Assigned to Arm(s): N/A | Intervention Type: OTHER; Name: internet-based intervention; Assigned to Arm(s): N/A
D: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Procedure: Dose adjustment of nicotine replacement therapies | Arm Label: 2; Type: OTHER; Interventions: Drug: nicotine patch | Intervention Type: PROCEDURE; Name: Dose adjustment of nicotine replacement therapies; Assigned to Arm(s): 1 | Intervention Type: DRUG; Name: nicotine patch; Assigned to Arm(s): 2

Answer: B