Effects of Varenicline and Cognitive Training on Brain Response to Smoking Cues

Phase 1

• Conditions: Healthy volunteer trial: Neural responses to smoking cues Intended indication (Smoking cessation); Therapeutic area: Psychiatry and Psychology [F] - Behaviours [F01]

• Registration Number: EUCTR2011-004169-34-GB
• Lead Sponsor: niversity of Bristol

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-01-05
• Study Completion: 2014-07-01
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 89

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

• 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified