Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Novel Treatment to Boost Quit Attempts and Cessation Among Unmotivated Smokers
Brief Summary: A sample of smokers who have no current plans to quit will be recruited for this study and randomized to one of two intervention conditions:

1. Practice Quit Attempt (PQA) aided by brief advice and self-help materials, or
2. PQA aided by advice and self-help materials plus nicotine replacement therapy (NRT).

This study will test whether adding free nicotine replacement therapy to brief advice to undertake a practice quit attempt will motivate more smokers to make a serious attempt to stop smoking than brief advice without NRT. All treatments and assessments will be delivered via telephone and mailing. The primary outcome of interest is the incidence of a serious attempt to permanently stop smoking made over a six-month study period.

Our specific hypotheses are as follows:

Hypothesis 1: Helping smokers to make a practice quit attempt aided by NRT will result in a higher incidence of making a serious effort to quit smoking permanently, compared to an aided practice quit attempt without NRT. We also expect provision of NRT will increase point prevalence abstinence at 6 month follow-up.

Hypothesis 2: This relationship between NRT-aided practice quit attempts and quit behaviors will be mediated by a) increased smoking related self efficacy, b) increased belief in the efficacy of NRT, c) fewer concerns about adverse events of NRT, d) increased social support for not smoking, and e) less withdrawal distress and craving during the practice quit attempt.


Options:
A: Arm Label: A; Type: PLACEBO_COMPARATOR; Interventions: Drug: nicotine versus placebo | Arm Label: B; Type: EXPERIMENTAL; Interventions: Drug: nicotine versus placebo | Intervention Type: DRUG; Name: nicotine versus placebo; Assigned to Arm(s): A, B
B: Arm Label: PROOF cohort; Type: N/A; Interventions: N/A
C: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Other: Practice Quit Attempt plus nicotine lozenge | Arm Label: 2; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Practice Quit Attempt only | Intervention Type: OTHER; Name: Practice Quit Attempt plus nicotine lozenge; Assigned to Arm(s): 1 | Intervention Type: BEHAVIORAL; Name: Practice Quit Attempt only; Assigned to Arm(s): 2
D: Arm Label: Placebo (Slow Metabolizers); Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Arm Label: Varenicline (Slow Metabolizers); Type: ACTIVE_COMPARATOR; Interventions: Drug: Varenicline | Arm Label: Transdermal Nicotine (Slow Metabolizers); Type: ACTIVE_COMPARATOR; Interventions: Drug: Transdermal Nicotine | Arm Label: Placebo (Normal Metabolizers); Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Arm Label: Varenicline (Normal Metabolizers); Type: ACTIVE_COMPARATOR; Interventions: Drug: Varenicline | Arm Label: Transdermal Nicotine (Normal Metabolizers); Type: ACTIVE_COMPARATOR; Interventions: Drug: Transdermal Nicotine | Intervention Type: DRUG; Name: Varenicline; Assigned to Arm(s): Varenicline (Normal Metabolizers), Varenicline (Slow Metabolizers) | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo (Normal Metabolizers), Placebo (Slow Metabolizers) | Intervention Type: DRUG; Name: Transdermal Nicotine; Assigned to Arm(s): Transdermal Nicotine (Normal Metabolizers), Transdermal Nicotine (Slow Metabolizers)

Answer: C