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: Arm Label: Varenicline + Placebo Patch; Type: EXPERIMENTAL; Interventions: Drug: Varenicline, Drug: Placebo Patch, Behavioral: Questionnaires, Behavioral: Counseling Sessions, Other: Lab Session, Other: Saliva Test | Arm Label: Nicotine Patch + Placebo Tablet; Type: EXPERIMENTAL; Interventions: Drug: Nicotine Patch, Drug: Placebo Tablet, Behavioral: Questionnaires, Behavioral: Counseling Sessions, Other: Lab Session, Other: Saliva Test | Intervention Type: DRUG; Name: Varenicline; Assigned to Arm(s): Varenicline + Placebo Patch | Intervention Type: DRUG; Name: Nicotine Patch; Assigned to Arm(s): Nicotine Patch + Placebo Tablet | Intervention Type: DRUG; Name: Placebo Patch; Assigned to Arm(s): Varenicline + Placebo Patch | Intervention Type: DRUG; Name: Placebo Tablet; Assigned to Arm(s): Nicotine Patch + Placebo Tablet | Intervention Type: BEHAVIORAL; Name: Questionnaires; Assigned to Arm(s): Nicotine Patch + Placebo Tablet, Varenicline + Placebo Patch | Intervention Type: BEHAVIORAL; Name: Counseling Sessions; Assigned to Arm(s): Nicotine Patch + Placebo Tablet, Varenicline + Placebo Patch | Intervention Type: OTHER; Name: Lab Session; Assigned to Arm(s): Nicotine Patch + Placebo Tablet, Varenicline + Placebo Patch | Intervention Type: OTHER; Name: Saliva Test; Assigned to Arm(s): Nicotine Patch + Placebo Tablet, Varenicline + Placebo Patch
B: Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Arm Label: Varenicline; Type: EXPERIMENTAL; Interventions: Drug: Varenicline | Intervention Type: DRUG; Name: Varenicline; Assigned to Arm(s): Varenicline | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo
C: 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
D: Arm Label: varenicline; Type: ACTIVE_COMPARATOR; Interventions: Drug: varenicline tartrate (CP-526, 555-18) | Arm Label: placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: varenicline tartrate (CP-526, 555-18); Assigned to Arm(s): varenicline | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): placebo

Answer: C