Phase 3
Completed N=101
Use of Varenicline for 4-weeks Prior to Quitting
Source: ClinicalTrials.gov NCT00789074 ↗Enrolled (actual)
101
Serious AEs
2.0%
Results posted
Jun 2012
Primary outcomePrimary: Rating of Urges to Smoke 24 Hours and One Week After the Target Quit Date Assessed by Mood and Physical Symptoms Scale — 2.47; 2.88 units on a scale — p=0.14
Summary
Varenicline (Champix) is a relatively new medicine that is effective in helping people to quit smoking. It is normally started 1-week before stopping smoking and used for up to 12-24 weeks. We are trying to find out if using varenicline for an extended time (4-weeks) before stopping smoking is better than the standard 1-week of use prior to stopping.
The study will recruit 100 smokers who want to stop. They will be randomly allocated to receive varenicline(4-weeks) or placebo (3-weeks followed by 1-week of active treatment as indicated by standard prescribing practice), followed by a 12-week open label treatment period where all participants will receive varenicline.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rating of Urges to Smoke 24 Hours and One Week After the Target Quit Date Assessed by Mood and Physical Symptoms Scale |
2.47; 2.88 | 0.14 |
| SECONDARY Change in Pre-quit End-expired Carbon Monoxide Reading (CO) |
-14.85; -7.68 | <0.001 sig |
| SECONDARY Change in Pre-quit Cotinine Levels |
-184.69; -44.73 | <0.001 sig |
| SECONDARY Change in Pre-quit Ratings of Cigarette Satisfaction |
-1.48; -0.842 | <0.04 sig |
| SECONDARY Change in Pre-quit Cigarette Consumption |
-9.78; -5.68 | 0.02 sig |
| SECONDARY Change in MPSS Scores of Urges to Smoke and Cigarette Withdrawal Symptoms Throughout the First Four Weeks of Abstinence |
0.15; 0.15 | 0.97 |
Eligibility Criteria
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
- Used varenicline in the past 6 months
- Unable to fill in questionnaires in English
- Current psychiatric illness
- Current serious illness including uncontrolled hypertension and recent cardiac event
- Sensitivity to varenicline currently enrolled in other research projects.
Data sourced from ClinicalTrials.gov (NCT00789074). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.