Investigation to explore whether there is a synergistic effect between nicotine replacement therapy and guided bodyscanning on cigarette cravings and withdrawal symptoms

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2008
INTERVENTION: Participants will be randomly allocated to receive either 1. Active nicotine patch plus: 1.1. Guided bodyscanning audio 1.2. Passive control audio (a natural history text reading) 2. Placebo patch plus: 2.1. Guided bodyscanning audio 2.2. Passive control audio (a natural history text reading) Those who are assigned to the active nicotine patch conditions will complete a Fagerström Test for Nicotine Dependence (FTND) and depending on their individual level of dependence will be administered with either a 14 mg or 21 mg transdermal NiQuitin nicotine replacment patch at the beginning of the trial to be kept on for a maximum of 7 hours. Participation in all potential arms of the trial will last for a maximum of 7 hours. There will be no follow up period as the study is a brief lab‐based intervention. CONDITION: Smoking cessation ; Mental and Behavioural Disorders ; Mental and behavioural disorders due to use of tobacco PRIMARY OUTCOME: Strength of desire to smoke and tobacco withdrawal symptoms will be measured using the self‐report 7‐point Mood and Physical Symptoms Scale (MPSS), whereby 1 = 'not at all', 4 = 'somewhat' and 7 = 'extremely'.; ; All ratings will be made on a pre‐programmed palmtop computer which will prompt participants to ratings at:; 1. 10 am: Single set of ratings in the presence of the researcher; 2. 11 am: Single set of ratings in your natural environment; 3. 12 pm: Multiple rating at the intervals detailed below; 4. Between 1 pm and 4 pm (if necessary): Multiple ratings at the intervals detailed below:; Rating 1 (just before audio); Audio (10 minutes); Rating 2 (just after audio); Rating 3 (5 minutes after audio); Rating 4 (20 minutes after audio); Rating 5 (30 minutes after audio) SECONDARY OUTCOME: No secondary outcome measures INCLUSION CRITERIA: 1. Smokers 2. Aged 18 to 65 years, either sex 3. Consume at least 10 cigarettes a day, and have done for at least the last three consecutive years
Epistemonikos ID: 917571b70509efaea6aa3f9dc161a827a4be2123
First added on: Aug 21, 2024