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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01184664
Other study ID # qmul250510
Secondary ID 2010-022334-92
Status Completed
Phase Phase 3
First received August 17, 2010
Last updated October 10, 2012
Start date April 2011
Est. completion date October 2011

Study information

Verified date October 2012
Source Queen Mary University of London
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited Kingdom: Research Ethics Committee
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 117
Est. completion date October 2011
Est. primary completion date October 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Intervention

Drug:
Nicotine Patch
Varenicline + nicotine patch
Placebo
Varenicline + placebo patch
Varenicline
All participants will receive a standard dose of varenicline (12 weeks).

Locations

Country Name City State
United Kingdom Tobacco Dependence Research and Treatment Unit London
United Kingdom Tobacco Dependence Research Unit London

Sponsors (1)

Lead Sponsor Collaborator
Queen Mary University of London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Rating of urges to smoke one week after the target quit date assessed by Mood and Physical Symptoms Scale Rating of urges to smoke will be assessed using the Mood and Physical Symptoms Scale 1 week No
Secondary Validated abstinence rates over weeks 1-12 post target quit date 12 weeks post target quit date No
Secondary Rating of withdrawal symptoms up to 4-weeks post quitting assessed by Mood and Physical Symptoms Scale 4-weeks post quitting No
Secondary Profile of all adverse effects reported up to 12-weeks post quitting Up to 12-weeks post quitting Yes
Secondary Ratings of urges to smoke 24 hours after the target quit date Urges to smoke at 24 hours after the target quit date will be assessed using the Mood & Physical Symptoms Scale 24 hours No
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