ACTRN12616001355460
Terminated
Phase 3
A randomised controlled clinical trial to evaluate the effectiveness and safety of combining varenicline with nicotine e-cigarettes on smoking abstinence in people with co-existing mental health and drug and alcohol dependence conditions.
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Smoking
- Sponsor
- The University of Auckland
- Enrollment
- 15
- Status
- Terminated
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\*currently live in the Auckland region
- •\*are registered clients with Community Mental Health Services or Community Alcohol and Drug Services
- •\*smoke cigarettes daily
- •\*want to quit smoking
- •\*are at least 18 years of age
- •\*are able to provide written informed consent
- •\*have access to a telephone (mobile and/or landline)
- •\*are prepared to use varenicline alone or with e\-cigarettes
- •\*have tried to quit at least twice before with nicotine replacement therapy (NRT), and thus are eligible for special authority varenicline
Exclusion Criteria
- •\*are pregnant or breastfeeding.
- •\*are current users of other smoking cessation medications.
- •\*are enrolled in a smoking cessation programme or another cessation research study.
- •\*have used an e\-cigarette for more than one week in the last year for smoking cessation.
- •\*have contraindications for varenicline or nicotine e\-cigarettes.
- •\*another person in their household is already in the trial.
Outcomes
Primary Outcomes
Not specified
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