Whether disrupting reconsolidation by a noradrenergic beta-blocker provides long-term relief from nicotine-addiction.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
nicotine-verslaving
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Smokingstatus, as assessed by using an online smoking-diary.
Secondary outcome
- breath monoxide assessment;
- urine cotinine levels;
- questionnaires related to withdrawal symptoms.
Background summary
Smoking is one of the leading causes of preventable death globally. Quitting
before the age of 40 reduces the risk of dying from smoking-related diseases by
nearly 90%. Given that existing therapies have limited long-term efficacy,
there is a pressing need for innovation in the smoking cessation field.
Study objective
Whether disrupting reconsolidation by a noradrenergic beta-blocker provides
long-term relief from nicotine-addiction.
Study design
Double-blind randomized placebo-controlled trial.
Intervention
Single reactivation session of smoking-related behavior followed by the
administration of 40 mg of the noradrenergic beta-blocker propranolol.
Study burden and risks
Participants are receiving a short treatment that is expected to diminish their
nicotine-addictive behavior. Based on the SPC we expect that propranolol HCl
will be well tolerated and do not anticipate any serious adverse events.
Utrechtseweg 48
Zeist 3704 HE
NL
Utrechtseweg 48
Zeist 3704 HE
NL
Listed location countries
Age
Inclusion criteria
- aged between18 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.
Exclusion criteria
- cardiovascular diseases or irregular heartbeat;
- hypotension or hypertension;
- pregnancy or breastfeeding;
- epilepsy;
- current state of asthma or COPD, which necessitates medication use.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2018-002829-33-NL |
| CCMO | NL66903.018.18 |