Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Effects of a Tailored Dose of Varenicline on Post-quitting Urges to Smoke
Brief Summary: Varenicline is a partial nicotinic agonist which acts on alpha4 beta2 nicotinic receptors. It is presumed to alleviate withdrawal discomfort, but also to diminish rewarding effects of cigarettes. The standard varenicline dosing has been formulated to avoid adverse reactions (primarily nausea) in sensitive clients. The downside of this cautious approach is that a substantial proportion of clients may be under-dosed. A blanket dose increase would inevitably increase the incidence of side effects, but it is likely that tailoring varenicline dosing to clients' needs would be safe and may further increase varenicline's efficacy.

This study will recruit 200 smokers who report little change to their enjoyment of cigarettes and no nausea, during the first week of varenicline use. These smokers will be randomised to receive the standard dose plus placebo or plus individualised varenicline dose up to 5mg, titrated over the next week prior to their target quit day. Urges to smoke, and other withdrawal symptoms, experienced during the study period will be compared between groups to see if the tailored therapy may be useful.


Options:
A: Intervention Type: DRUG; Name: varenicline; Assigned to Arm(s): N/A
B: Arm Label: Healthy Control - Non-smoking; Type: OTHER; Interventions: Other: Biological Control | Arm Label: Healthy Control - Smoker; Type: OTHER; Interventions: Other: Biological Control | Arm Label: HIV Smoking Cessation Arm; Type: ACTIVE_COMPARATOR; Interventions: Drug: Varenicline tartrate, Drug: Nicotine Replacement Therapy | Arm Label: Motivational Intervention; Type: EXPERIMENTAL; Interventions: Behavioral: Motivational Interview | Intervention Type: DRUG; Name: Varenicline tartrate; Assigned to Arm(s): HIV Smoking Cessation Arm | Intervention Type: DRUG; Name: Nicotine Replacement Therapy; Assigned to Arm(s): HIV Smoking Cessation Arm | Intervention Type: OTHER; Name: Biological Control; Assigned to Arm(s): Healthy Control - Non-smoking, Healthy Control - Smoker | Intervention Type: BEHAVIORAL; Name: Motivational Interview; Assigned to Arm(s): Motivational Intervention
C: Arm Label: Combination zonisamide and bupropion with e-cigarette; Type: EXPERIMENTAL; Interventions: Drug: Bupropion, Drug: Zonisamide, Other: E-cigarette | Arm Label: Bupropion with e-cigarette; Type: EXPERIMENTAL; Interventions: Drug: Bupropion, Drug: Placebo zonisamide, Other: E-cigarette | Arm Label: Placebo with e-cigarette; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo bupropion, Drug: Placebo zonisamide, Other: E-cigarette | Intervention Type: DRUG; Name: Bupropion; Assigned to Arm(s): Bupropion with e-cigarette, Combination zonisamide and bupropion with e-cigarette | Intervention Type: DRUG; Name: Zonisamide; Assigned to Arm(s): Combination zonisamide and bupropion with e-cigarette | Intervention Type: DRUG; Name: Placebo bupropion; Assigned to Arm(s): Placebo with e-cigarette | Intervention Type: DRUG; Name: Placebo zonisamide; Assigned to Arm(s): Bupropion with e-cigarette, Placebo with e-cigarette | Intervention Type: OTHER; Name: E-cigarette; Assigned to Arm(s): Bupropion with e-cigarette, Combination zonisamide and bupropion with e-cigarette, Placebo with e-cigarette
D: Arm Label: Varenicline + Active Tailored Dose; Type: EXPERIMENTAL; Interventions: Drug: Varenicline | Arm Label: Varenicline + Placebo Tailored Dose; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo, Drug: Varenicline | Intervention Type: DRUG; Name: Varenicline; Assigned to Arm(s): Varenicline + Active Tailored Dose | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Varenicline + Placebo Tailored Dose | Intervention Type: DRUG; Name: Varenicline; Assigned to Arm(s): Varenicline + Active Tailored Dose, Varenicline + Placebo Tailored Dose

Answer: D