Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A 10-Week Pilot Study of Varenicline (Champix) Versus Placebo for Smoking Cessation/Reduction in Patients With Bipolar Disorder
Brief Summary: Bipolar Disorder is a chronic relapsing mental disorder characterized by periods of elevated, expansive and irritable mood, often alternating with periods of significant clinical depression. People with Bipolar Disorder are typically heavy smokers who have difficulty quitting, and this is associated with significant tobacco-related medical illness and death.

The proposed study will be a double-blind, placebo-controlled 10-week clinical trial of the safety and efficacy of varenicline (Champix™) in thirty subjects with Bipolar I Disorder. This medication is the latest first-line pharmacotherapy for smoking cessation and has been shown to be efficacious for smoking cessation, but has not yet been systematically studied in persons with Bipolar Disorder.


Options:
A: Arm Label: Extended Brief Contact; Type: EXPERIMENTAL; Interventions: Drug: Varenicline, Behavioral: Initial Individual counseling, Behavioral: Check-ins with medical staff | Arm Label: Extended Health Education; Type: EXPERIMENTAL; Interventions: Drug: Varenicline, Behavioral: Initial Individual counseling, Behavioral: Extended Individual Counseling - Health Model | Arm Label: Extended Relapse Prevention plus varenicline; Type: EXPERIMENTAL; Interventions: Drug: Varenicline, Behavioral: Initial Individual counseling, Behavioral: Extended Individual Counseling - Relapse Prevention Model | Arm Label: Extended Relapse Prevention; Type: EXPERIMENTAL; Interventions: Drug: Varenicline, Behavioral: Initial Individual counseling, Behavioral: Extended Individual Counseling - Relapse Prevention Model | Intervention Type: DRUG; Name: Varenicline; Assigned to Arm(s): Extended Brief Contact, Extended Health Education, Extended Relapse Prevention, Extended Relapse Prevention plus varenicline | Intervention Type: BEHAVIORAL; Name: Initial Individual counseling; Assigned to Arm(s): Extended Brief Contact, Extended Health Education, Extended Relapse Prevention, Extended Relapse Prevention plus varenicline | Intervention Type: BEHAVIORAL; Name: Check-ins with medical staff; Assigned to Arm(s): Extended Brief Contact | Intervention Type: BEHAVIORAL; Name: Extended Individual Counseling - Health Model; Assigned to Arm(s): Extended Health Education | Intervention Type: BEHAVIORAL; Name: Extended Individual Counseling - Relapse Prevention Model; Assigned to Arm(s): Extended Relapse Prevention, Extended Relapse Prevention plus varenicline
B: Arm Label: Tailored Intervention Group; Type: EXPERIMENTAL; Interventions: Drug: Nicotine replacement therapy - transdermal nicotine patch, Behavioral: Tailored behavioral intervention, Drug: Nicotine replacement therapy - nicotine gum, Drug: Nicotine replacement therapy - nicotine lozenge, Drug: Bupropion Sustained Release, Drug: Varenicline, Drug: Combination pharmacotherapy - transdermal nicotine patch + nicotine gum, Drug: Combination pharmacotherapy - transdermal nicotine patch + nicotine lozenge, Drug: Combination pharmacotherapy - transdermal nicotine patch + bupropion, Behavioral: Alcohol use risk reduction, Behavioral: Behavioral activation for the treatment of depression, Behavioral: Behavioral management of post-cessation weight gain | Arm Label: Enhanced Standard of Care Group; Type: ACTIVE_COMPARATOR; Interventions: Drug: Nicotine replacement therapy - transdermal nicotine patch, Behavioral: Tobacco quit line referral, Drug: Nicotine replacement therapy - nicotine gum, Drug: Nicotine replacement therapy - nicotine lozenge, Drug: Bupropion Sustained Release, Drug: Varenicline, Drug: Combination pharmacotherapy - transdermal nicotine patch + nicotine gum, Drug: Combination pharmacotherapy - transdermal nicotine patch + nicotine lozenge, Drug: Combination pharmacotherapy - transdermal nicotine patch + bupropion | Intervention Type: DRUG; Name: Nicotine replacement therapy - transdermal nicotine patch; Assigned to Arm(s): Enhanced Standard of Care Group, Tailored Intervention Group | Intervention Type: BEHAVIORAL; Name: Tailored behavioral intervention; Assigned to Arm(s): Tailored Intervention Group | Intervention Type: BEHAVIORAL; Name: Tobacco quit line referral; Assigned to Arm(s): Enhanced Standard of Care Group | Intervention Type: DRUG; Name: Nicotine replacement therapy - nicotine gum; Assigned to Arm(s): Enhanced Standard of Care Group, Tailored Intervention Group | Intervention Type: DRUG; Name: Nicotine replacement therapy - nicotine lozenge; Assigned to Arm(s): Enhanced Standard of Care Group, Tailored Intervention Group | Intervention Type: DRUG; Name: Bupropion Sustained Release; Assigned to Arm(s): Enhanced Standard of Care Group, Tailored Intervention Group | Intervention Type: DRUG; Name: Varenicline; Assigned to Arm(s): Enhanced Standard of Care Group, Tailored Intervention Group | Intervention Type: DRUG; Name: Combination pharmacotherapy - transdermal nicotine patch + nicotine gum; Assigned to Arm(s): Enhanced Standard of Care Group, Tailored Intervention Group | Intervention Type: DRUG; Name: Combination pharmacotherapy - transdermal nicotine patch + nicotine lozenge; Assigned to Arm(s): Enhanced Standard of Care Group, Tailored Intervention Group | Intervention Type: DRUG; Name: Combination pharmacotherapy - transdermal nicotine patch + bupropion; Assigned to Arm(s): Enhanced Standard of Care Group, Tailored Intervention Group | Intervention Type: BEHAVIORAL; Name: Alcohol use risk reduction; Assigned to Arm(s): Tailored Intervention Group | Intervention Type: BEHAVIORAL; Name: Behavioral activation for the treatment of depression; Assigned to Arm(s): Tailored Intervention Group | Intervention Type: BEHAVIORAL; Name: Behavioral management of post-cessation weight gain; Assigned to Arm(s): Tailored Intervention Group
C: Intervention Type: DRUG; Name: varenicline; Assigned to Arm(s): N/A
D: Arm Label: Varenicline; Type: EXPERIMENTAL; Interventions: Drug: Varenicline | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Varenicline; Assigned to Arm(s): Varenicline | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo

Answer: C