nicotine addiction
Conditions
Interventions
Trade Name: Propranolol Hcl
Pharmaceutical Form: Capsule
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
Sponsors
TNO
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: - cardiovasculaire diseases or irregular heartbeat; - hypotension or hypertension; - pregnancy or breastfeeding; - epilepsy; - current state of asthma or COPD, which necessitates medication use.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): - breath monoxide assessment: < 10ppm CO; - urine cotinine levels: < 10 ng-mL; - ten-item questionnaire on smoking urges (QSU-brief): craving; - mood and physical symptom scale (MPSS): withdrawal symptoms.;Timepoint(s) of evaluation of this end point: 7-days and 3-months post-treatment. | — |
Countries
Netherlands
Contacts
Public Contactclinical_trial information
TNO
Outcome results
None listed