Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: EVarQuit: Extended Pre-quit Varenicline to Assist in Quitting Smoking
Brief Summary: Varenicline is the most effective smoking cessation therapy available. Nevertheless, most smokers using varenicline relapse within the first few months after quitting. Varenicline is hypothesized to help smokers to quit in part by reducing the reinforcing effects of smoking during the standard 1-week pre-quitting treatment phase. Learning theory and previous human and animal research support the hypothesis that a longer period of varenicline treatment prior to the target quit date (TQD) will lead to greater reductions in smoking before quitting, and higher long-term cessation rates, compared to standard varenicline treatment. Building on promising preliminary clinical data, the study tests these hypotheses with a full-scale randomized clinical trial (RCT). 320 treatment-seeking smokers will be randomized to a standard run-in group (3 weeks of placebo, followed by the standard 1 week of pre-TQD varenicline) or an extended run-in group (4 weeks of pre-TQD varenicline). Both groups will receive brief individual cessation counseling and 11 weeks of post-TQD varenicline. The primary outcome measure will be bio-verified continuous abstinence at end-of-treatment (weeks 8-11 post-quit; cessation at 26-weeks post TQD will also be examined. Hypothesized mediating mechanisms (e.g., smoking reinforcement) will be evaluated by behavioral, physiological, and subjective measures assessed both in the lab and using real-world, real-time electronic momentary assessments (EMA). The investigators predict that long-term, bio-verified smoking cessation will be improved among the extended run-in group compared to the standard run-in group. The investigators further predict the improved clinical outcomes with extended run-in varenicline will be explained (or mediated) by greater pre-quit reductions in smoking reinforcement among the extended run-in group compared to the standard run-in group. The significance of this work is clear: The project aims to make best available treatment for smoking cessation even better, using a method that is ripe for dissemination and an approach that will elucidate critical mechanisms to target in the next generation of treatment enhancement.


Options:
A: Arm Label: placebo; Type: EXPERIMENTAL; Interventions: Drug: placebo | Arm Label: varenicline; Type: EXPERIMENTAL; Interventions: Drug: varenicline tartrate | Arm Label: bupropion; Type: EXPERIMENTAL; Interventions: Drug: bupropion hydrochloride | Arm Label: Nicotine Replacement Therapy Patch; Type: EXPERIMENTAL; Interventions: Drug: Nicotine Replacement Therapy Patch | Intervention Type: DRUG; Name: placebo; Assigned to Arm(s): placebo | Intervention Type: DRUG; Name: varenicline tartrate; Assigned to Arm(s): varenicline | Intervention Type: DRUG; Name: bupropion hydrochloride; Assigned to Arm(s): bupropion | Intervention Type: DRUG; Name: Nicotine Replacement Therapy Patch; Assigned to Arm(s): Nicotine Replacement Therapy Patch
B: Arm Label: Extended Run-In; Type: EXPERIMENTAL; Interventions: Drug: Varenicline, Behavioral: Brief smoking cessation counseling | Arm Label: Standard Run-In; Type: ACTIVE_COMPARATOR; Interventions: Drug: Varenicline, Behavioral: Brief smoking cessation counseling | Intervention Type: DRUG; Name: Varenicline; Assigned to Arm(s): Extended Run-In, Standard Run-In | Intervention Type: BEHAVIORAL; Name: Brief smoking cessation counseling; Assigned to Arm(s): Extended Run-In, Standard Run-In
C: Arm Label: Varenicline treatment as usual (TAU); Type: EXPERIMENTAL; Interventions: Drug: Varenicline | Arm Label: Varenicline directly observed therapy; Type: EXPERIMENTAL; Interventions: Drug: Varenicline | Intervention Type: DRUG; Name: Varenicline; Assigned to Arm(s): Varenicline directly observed therapy, Varenicline treatment as usual (TAU)
D: Arm Label: placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Arm Label: varenicline; Type: ACTIVE_COMPARATOR; Interventions: Drug: varenicline tartrate | Arm Label: bupropion; Type: ACTIVE_COMPARATOR; Interventions: Drug: bupropion hydrochloride | Arm Label: Nicotine Replacement Therapy Patch; Type: ACTIVE_COMPARATOR; Interventions: Drug: Nicotine Replacement Therapy Patch | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): placebo | Intervention Type: DRUG; Name: varenicline tartrate; Assigned to Arm(s): varenicline | Intervention Type: DRUG; Name: bupropion hydrochloride; Assigned to Arm(s): bupropion | Intervention Type: DRUG; Name: Nicotine Replacement Therapy Patch; Assigned to Arm(s): Nicotine Replacement Therapy Patch

Answer: B