Combination of Nicotine Replacement Therapy (NRT) and Varenicline to Increase Cessation of Tobacco (CONVICT Study)

Queen Mary University of London

Status and phase: Completed; Phase 3

Conditions: Tobacco Dependence; Smoking Cessation

Treatments: Drug: Nicotine Patch; Drug: Placebo; Drug: Varenicline

Study type: Interventional

Funder types: Other

Identifiers

NCT01184664

qmul250510

2010-022334-92 (EudraCT Number)

Details and patient eligibility

About

Varenicline and nicotine replacement therapy (NRT) are both effective smoking cessation treatments. Anecdotally smokers who are finding their quit attempt difficult have reported benefiting from adding NRT to varenicline. This proof-of-principle placebo-controlled double-blind study will examine whether combining NRT and varenicline provides better withdrawal and craving relief than varenicline alone. A total of 120 smokers would be randomised to receive varenicline +15mg/16hr patch or varenicline + placebo patch. All participants will receive standard NHS Stop Smoking Service support. The primary outcome would be ratings of craving and withdrawal discomfort 24 hours and one week after the target quit date.

Enrollment: 117 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Smokers seeking treatment
• Aged 18 and over
• Consenting to take part in the trial

Exclusion criteria

• Pregnant or breastfeeding
• End-stage renal disease
• Unable to fill in questionnaires in English
• Previous allergy to Varenicline
• Previous allergy to Nicotine Patches Previous allergy to varenicline

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

117 participants in 2 patient groups, including a placebo group

Varenicline + Active Patch

Experimental group

Description:

Participants will use varenicline (1mg BD) + an active, 15mg/16hr Nicotine Patch

Treatment:

Drug: Varenicline

Drug: Nicotine Patch

Varenicline + Placebo Patch

Placebo Comparator group

Description:

Participants will use varenicline (1mg BD) + a Placebo Nicotine Patch

Treatment:

Drug: Varenicline

Drug: Placebo