HARMONY: Harm reduction for Opiates, Nicotine and You.

Phase 4

Active, not recruiting

• Conditions: Tobacco smoking; Public Health - Health service research; Mental Health - Addiction

• Registration Number: ACTRN12621000148875
• Lead Sponsor: Hunter New England Area Health Service

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-02-12
• Last Update Posted: 5 February 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 502

Inclusion Criteria

Inclusion Criteria
•Provide written, informed consent to participate in the study.
•Aged 18 to 65 years
•Be accessing opioid agonist treatment from a participating service
•Current daily tobacco smokers on self-report
•Want to quit or cut down their tobacco smoking
•Be willing and able to comply with requirements of study (including having access to a phone)

Exclusion Criteria

•Currently breastfeeding or pregnant, or of childbearing potential and planning/trying to fall pregnant during the study period
•Current, severe medical disorder assessed by study medical officer (such as but not limited to, unstable cardiovascular/peripheral vascular disease, poorly controlled hypertension)
•Current, severe and unstable psychiatric disorder assessed by study medical officer (such as but not limited to, acute psychosis, severe anxiety and/or mood disorder, intent to harm self or others)
•Current enrollment in a clinical trial involving any investigational drug
•Regular use (more than one day per week) of VNP or e-Cigarette containing nicotine in the last 30 days
•Not available for follow-up (e.g. likely imprisonment or transfer out of service to another service that is not a trial recruitment site)

Study & Design

• Study Type: Interventional
• Study Design: Not specified