A new treatment for smoking cessation.
Phase 1
- Conditions
- nicotine addictionTherapeutic area: Psychiatry and Psychology [F] - Behaviours [F01]
- Registration Number
- EUCTR2018-002829-33-NL
- Lead Sponsor
- TNO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
- aged between 18 and 65 years;
- smoking 10 or more cigarettes per day for at least 12 months;
- written approval of participant's own general practitioner for participation.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- cardiovasculaire diseases or irregular heartbeat;
- hypotension or hypertension;
- pregnancy or breastfeeding;
- epilepsy;
- current state of asthma or COPD, which necessitates medication use.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Our study will test whether disrupting reconsolidation by the noradrenergic beta-blocker propranolol (i.e., 40mg) provides long-term relief from nicotine addiction.;Secondary Objective: not applicable;Primary end point(s): Quit smoking: not a single puff, as assessed by a daily online smoking diary.;Timepoint(s) of evaluation of this end point: 3-months post-treatment.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): - breath monoxide assessment: < 10ppm CO;<br>- urine cotinine levels: < 10 ng-mL;<br>- ten-item questionnaire on smoking urges (QSU-brief): craving;<br>- mood and physical symptom scale (MPSS): withdrawal symptoms.;Timepoint(s) of evaluation of this end point: 7-days and 3-months post-treatment.