None listed
Conditions
Brief summary
There is mounting evidence of widespread use of vaporised nicotine products (VNPs) among the general population of smokers. There is also evidence of their effectiveness at achieving short-term cessation with few reported side effects, although limited long term efficacy and safety data is available. VNPs may offer a harm reduction approach to tobacco in populations such as people living with HIV who have high rates of smoking and experience significant associated health consequences. This study will examine whether such products that deliver liquid nicotine are acceptable to people living with HIV who smoke and whether a larger, randomised controlled trial to assess long-term cessation outcomes and relapse prevention would be feasible.
Interventions
The study is an uncontrolled study of a harm reduction intervention, using vaporised nicotine in people living with HIV who smoke cigarettes.
Participants will receive two study devices (Innokin Endura T18, and Innokin Endura T22) each device is a type of vaporised nicotine product that deliver the study medicine (Nicophar brand nicotine liquid, containing; 1.2% nicotine, 82.8% glycerol and water 16%) to use over a 12 week treatment period and asked to replace as many cigarettes as possible (if
The study is an uncontrolled study of a harm reduction intervention, using vaporised nicotine in people living with HIV who smoke cigarettes. Participants will receive two study devices (Innokin Endura T18, and Innokin Endura T22) each device is a type of vaporised nicotine product that deliver the study medicine (Nicophar brand nicotine liquid, containing; 1.2% nicotine, 82.8% glycerol and water 16%) to use over a 12 week treatment period and asked to replace as many cigarettes as possible (if not all) with use of the vaporised nicotine products (VNPs). Participants are free to use both devices interchangeably or only one based on their own own personal preference over the 12 week treatment period. The study will investigate they way people use the VNPs and what they think of the devices and people use the VNPs based on their needs and preferences, adherence is therefore not measured in this study. Participants will receive 10 x 10mL bottles of e-liquid for every four-week period to use. This concentration is in common use and recommended by the manufacturer as the most appropriate strength to be used with the Innokin Endura devices. The device administers the liquid nicotine to reduce tobacco withdrawal symptoms, such as craving cigarettes (similar to other fast acting NRT products). The frequency with which the device (and its liquid nicotine) is used is therefore dependent on the user's level of nicotine dependence. Literature suggests people who use vaporised nicotine self-titrate, similar to their self-titration of tobacco cigarettes or NRT products. Participants will also receive an 'intervention pack' containing; a. A list of participant instructions b. A “Positively Quitting” booklet designed to help people living with HIV to quit smoking (this booklet was developed by and available from Queensland Positive People, a peer-based advocacy organisation for people living with HIV. c. Information on using the devices instead of smoking instructions on how to use, store and handle the investigational products d. Copies of device user manuals e. Links and information on quitting supports (such as Quitline) f. A study wallet card to confirm participation in trial
Sponsors
The University of Queensland
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. A diagnosis of HIV 2. Aged 18 years (or over) 3. Smoke 5 (or more) cigarettes per day, at the time of enrolment into the trial 4. Have been smoking for at least 12 months 5. Have capacity to consent and able to understand study instructions and procedures (e.g. sufficient English language ability). 6. Willing to attempt to quit tobacco smoking within 1 week of enrolment
Exclusion criteria
1. Currently participating in a smoking-cessation program 2. Aged <18 years 3. Currently pregnant, measured by self-report, with confirmation by self-administered pregnancy test where there is doubt, or planning to become pregnant during trial participation period 4. Currently breast-feeding (measured by self-report) or planning to be during trial participation period 5. Insufficient capacity to provide informed consent or complete the study requirements (e.g. completing surveys in English) 6. Has experienced chest pain, or another cardiovascular event or procedure (e.g. heart attack, stroke, insertion of stent, bypass surgery) in the last month 7. Being treated with oxygen therapy.
Outcome results
None listed