Can electronic cigarettes and nicotine replacement treatment help reduce smoking in smokers who struggle to quit?

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2017
INTERVENTION: Participants will be invited to attend two appointments as follows: Visit 1 ‐ Screening for eligibility, baseline data collection and randomisation. Smokers attend to confirm eligibility, have questions answered, and provide consent. Baseline data collected. Participants randomised to EC or NRT, select products of their choice and receive instructions on how to obtain them. Continue to smoke ad‐lib. Visit 2 – Preparation Smokers bring allocated product to the session, receive advice on use, test and start product use. Commitment to not using unallocated products for the next four weeks. Smoking reduction counselling will be provided. Participants will be randomised to two different study arms: NRT group and e‐cigarette group. Randomisation (1:1 in blocks of 20) will be undertaken using computer generated randomisation codes that will be prepared in advance. Codes will be sealed in opaque envelopes that will be marked with a randomisation number. Randomisation numbers will be allocated sequentially. The staff randomising the participant will open the envelope and enter the allocation onto the clinical record form (CRF). NRT group product details Those allocated to the NRT group will be shown and explained the NRT products available and encouraged to choose a product or product combination that suits their needs. They will receive a letter of recommendation (LOR) as per standard practice and collect their chosen products at local pharmacies. Product use will be supervised and adjusted (if required) as part of the behavioural support package. As per local standard practice, NRT will be provided for up to 8 weeks. EC group product details Those allocated to the EC group will be shown and explained different EC products commonly used and asked to obtain the product of their choice either using a voucher for up to £35 to purchase EC at a local vape shop, purchase from other suppliers and claim a refund of up to £35 upon providing a valid receipt, or choose from a CONDITION: Smoking cessation ; Mental and Behavioural Disorders PRIMARY OUTCOME: Cigarette consumption per day, assessed by self‐report in the follow up survey created for the purpose of the study at 1, 4 and 24 weeks post quit date/preparation date. Those who will report =50% smoking reduction will be validated with a CO reading in the clinic. SECONDARY OUTCOME: 1. Use of allocated harm reduction strategies; 2. Strategy ratings; 3. Changes in smoking behaviour; 4. Proportion of people still using allocated strategy at 6 months; All measured by the follow up survey created for the purpose of the study at 1, 4 and 24 weeks post quit date/preparation date INCLUSION CRITERIA: 1. 18 years or older 2. Able to provide written informed consent 3. History of failed quit attempts using stop smoking medications and/or stop smoking services 4. Willing to use their allocated harm‐reduction strategy for at least 4 weeks
Epistemonikos ID: 150491d34c652f084b7910324b947f2fb6a31ae1
First added on: Aug 23, 2024