Healthy volunteer trial: Neural responses to smoking cues Intended indication (Smoking cessation)
Conditions
Interventions
Trade Name: Champix
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Sponsors
University of Bristol
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Smokes > 10 manufactured cigarettes or > 15 roll up cigarettes per day. • Smokes within one hour of waking. • Aged between 18 and 40 years. • Able to attend all of the study sessions. • English as first language or equivalent level of fluency. • Able to give informed consent as judged by lead researcher. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 72 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: • Female volunteers who are pregnant or breast feeding. • Female volunteers not using adequate contraception. • Volunteers who do not currently have a GP. • Current or previous substance or alcohol misuse or dependence [other than nicotine] Alcohol use in excess of 35 Units/week if female or 50 Units/week if male. • Caffeine use = 8 cups per day. • Significant current or past psychiatric illness (Axis 1 or 2 psychiatric diagnoses) as diagnosed by a psychiatrist. • Clinically significant abnormality including cardiology risk factors and history of arrhythmia (as assessed by self-report). • Ongoing use of medication (i.e. intake of any medication within 8 weeks of study, with exception of local treatment and occasional paracetamol or non-steroidal anti-inflammatory drugs, e.g., aspirin or ibuprofen). • Smokers actively trying to give up smoking during the study period. • Uncorrected visual impairment (including colour-blindness). • Uncorrected auditory impairment. • Condition that make MRI scanning unsafe (e.g. metallic implants; history of metal-working). • Unable to tolerate scanning environment (as established during a short anatomical MRI scan on day 0). • Hypersensitivity to Champix.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1) Does cognitive bias modification alter neural response to smoking-related cues? H1a: We hypothesise that experimental procedures designed to induce attentional bias towards smoking-relates cues will lead to an increase in neural response to smoking-related cues, in brain regions previously implicated in cue reactivity in cigarette smokers. H1b: We hypothesise that experimental procedures designed to induce attentional bias away from smoking-relates cues will lead to a decrease in neural response to smoking-related cues, in brain regions previously implicated in cue reactivity in cigarette smokers.;Secondary Objective: 2) Does cognitive bias modification alter attentional bias to smoking-related cues? H2a: We hypothesise that experimental procedures designed to induce attentional bias away from smoking-relates cues will lead to a decrease in attentional bias from pre-training to post-training. H2b: We hypothesise that experimental procedures designed to induce attentional bias towards smoking-relates cues will lead to an increase in attentional bias from pre-training to post-training. 3) Are the effects of cognitive bias modification potentiated by varenicline? H3: We hypothesise that changes in the neural response to smoking-related cues relative to neutral cues, and changes in attentional bias, will be greatest in those trained to attend away from smoking-related cues and treated with varenicline.;Primary end point(s): 1. Neural responses to smoking-related cues (fMRI; brain activation during viewing of smoking-related and control cues) 2. Cognitive bias (Stroop task);Timepoint(s) of evaluation of this end point: N/a | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): N/a;Timepoint(s) of evaluation of this end point: N/a | — |
Countries
United Kingdom
Contacts
Public ContactDr Birgit Whitman
University of Bristol, Research Enterprise and Development
Outcome results
None listed