Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Extended Duration Pharmacotherapy for Prevention of Relapse to Smoking
Brief Summary: Varenicline (Chantix) is a smoking cessation treatment that was approved in 2006 by the FDA for treatment of nicotine dependence and may be particularly beneficial in smokers with schizophrenia or bipolar disorder. Early experience with varenicline indicates that it will be effective for smoking cessation in schizophrenia and in addition, has the potential to be therapeutic for cognitive dysfunction in this population. In addition, more data is needed to evaluate the safety, tolerability and effectiveness of Varenicline in people with bipolar disorder.

To assess this possibility, we will evaluate the safety and efficacy of 12 months of varenicline in schizophrenia or bipolar disorder patients who are able to quit smoking in the short term with this treatment. To do so, we will enroll 324 smokers with schizophrenia or bipolar disorder from 6 mental health clinics in Massachusetts, New Hampshire, Michigan and Minnesota into an open, 12-week smoking cessation program that includes varenicline added to weekly group cognitive behavioral therapy (CBT). Those who achieve at least 2 weeks of continuous abstinence during the last 2 weeks of the open intervention will be randomized to the relapse prevention phase: a 40-week, double blind, placebo-controlled trial of varenicline at the dose used to quit smoking added to a tapering CBT schedule. Participants will then discontinue study medications and behavioral treatment and enter a 3-month follow up phase.


Options:
A: Arm Label: Longitudinal Care; Type: EXPERIMENTAL; Interventions: Behavioral: smoking cessation | Arm Label: Usual Care; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: smoking cessation | Intervention Type: BEHAVIORAL; Name: smoking cessation; Assigned to Arm(s): Longitudinal Care, Usual Care
B: Arm Label: Randomized Phase: Varenicline; Type: ACTIVE_COMPARATOR; Interventions: Drug: Varenicline | Arm Label: Randomized Phase: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Varenicline; Assigned to Arm(s): Randomized Phase: Varenicline | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Randomized Phase: Placebo
C: Arm Label: virtual reality exposure therapy (VRET); Type: EXPERIMENTAL; Interventions: Other: virtual reality exposure treatment | Arm Label: cognitive and behavioral approaches therapy without VRET; Type: EXPERIMENTAL; Interventions: Other: cognitive and behavioral approaches therapy | Intervention Type: OTHER; Name: virtual reality exposure treatment; Assigned to Arm(s): virtual reality exposure therapy (VRET) | Intervention Type: OTHER; Name: cognitive and behavioral approaches therapy; Assigned to Arm(s): cognitive and behavioral approaches therapy without VRET
D: Arm Label: 1; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Extended IVR (integrated voice response technology), Drug: Varenicline (Champix), Behavioral: IVR treatment | Arm Label: 2; Type: ACTIVE_COMPARATOR; Interventions: Drug: Varenicline (Champix), Behavioral: IVR treatment | Intervention Type: BEHAVIORAL; Name: Extended IVR (integrated voice response technology); Assigned to Arm(s): 1 | Intervention Type: DRUG; Name: Varenicline (Champix); Assigned to Arm(s): 1, 2 | Intervention Type: BEHAVIORAL; Name: IVR treatment; Assigned to Arm(s): 1, 2

Answer: B