A multi-component intervention for smoking cessation among Australian male prison inmates
Phase 3
Completed
- Conditions
- Mental Health - AddictionTobacco Addiction
- Registration Number
- ACTRN12606000229572
- Lead Sponsor
- niversity of New South Wales
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 426
Inclusion Criteria
Has been incarcerated for >1 month with >6 months of the current sentence remaining; English speaker; scores >5 on the Fagerström Test for Nicotine Dependence (indicates moderate to high nicotine dependence); readiness to quit.
Exclusion Criteria
current significant cardiovascular disease (e.g. evidence of conduction defects on ECG); Current major depressive disorder; bipolar disorder; current antidepressant or antipsychotic medication; threats of suicide or repeated deliberate self harm; current psychotic disorder; use of a monoamine oxidase inhibitors within two weeks; known allergies to the study drugs; life threatening illness.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Point prevalence abstinence. Point prevalence is defined as the proportion of subjects who have not smoked at all during a particular time period and allows for the inclusion a grace period. [At 12 months. Also reported for the 3 and 6 month follow-ups.];Continued abstinence. Continuous abstinence is defined as abstinence between quit day and a specified follow-up period 3 months, 6 months and 12 months.[At 12 months. Also reported for the 3 and 6 month follow-ups.]
- Secondary Outcome Measures
Name Time Method Anxiety & depression measured by the PRIME and Kessler 10 (K-10).[Initial screening.Also reported for 3month, 6 month and 12 month follow ups.];Physical and mental wellness measured by the Short Form 12 (SF-12).[Short Form 12 ( SF-12) Initial screening.Also reported for 3month, 6 month and 12 month follow ups.]