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A pill against anxiety


- candidate number22752
- NTR NumberNTR5364
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR16-aug-2015
- Secondary IDsNL42210.018.13 ClinicalTrials.gov identifier: NCT02268357
- Public TitleA pill against anxiety
- Scientific TitleEffects of propranolol on fear of dental extraction: study protocol for a multicenter randomized placebo-controlled trial
- ACRONYM
- hypothesisThe primary aim of this study is to determine whether administration of the active substance (two 40 mg propranolol capsules one hour prior to dental extraction, followed by one 40 mg capsule directly postoperatively) results in a significantly greater reduction of dental trait anxiety in patients with self-reported high to extreme fear in anticipation of dental extraction, compared to the effects of the placebo comparator, from baseline to 4-week follow-up appointment.
To determine whether the use of propranolol in patients with high self-reported levels of fear in anticipation of tooth or molar removal results in:
(1) a significantly greater reduction of self-reported intraoperative (state) anxiety, compared to the placebo comparator, from baseline to 4-week follow-up appointment;
(2) a significantly greater decrease of physiological responding during recall of the crucial fear-related memory in, compared to the placebo comparator, from baseline to 4-week follow-up appointment;
(3); a significantly greater loss of specific phobia diagnoses, compared to the placebo comparator, from baseline to 4-week follow-up appointment;
(4) a significantly greater reduction of self-reported vividness and emotional charge of the crucial fear-related memory scores, compared to the placebo comparator, from baseline to 4-week follow-up appointment.
- Healt Condition(s) or Problem(s) studiedDental phobia, Fear of dental extractions
- Inclusion criteria1. Signed written informed consent
2. Minimum age of 18 years on entry to the study
3. Self-reported high to extreme fear of tooth or molar removal
4. Dutch or English-speaking
- Exclusion criteria1. Asthma or other obstructive pulmonary disease
2. Cardiac failure
3. Cardiac arrythmia
4. Renal failure
5. Insulin-dependent diabetes mellitus
6. Pregnant or breast-feeding
7. Current use of another ß-adrenoreceptor antagonist
8. Current use of anxyiolytic or antidepressant medication
9. Currently in psychotherapy for dental anxiety
10. Systolic blood pressure < 100 mmHg
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 11-nov-2014
- planned closingdate12-dec-2018
- Target number of participants34
- InterventionsTwo 40 mg propranolol capsules one hour prior to a dental extraction, followed by one 40 mg capsule directly postoperatively.
Comparator: Placebo capsules.
- Primary outcomeDental trait anxiety score reduction from baseline to 4-weeks follow-up.
- Secondary outcomeSelf-reported anxiety during surgery; physiological parameters (heart rate and blood pressure) during recall of the crucial fear-related memory; self-reported vividness and emotional charge of the crucial fear-related memory.
- Timepointst=0 screening
t=1 first dental extraction procedure
t=2 follow up: second dental extraction procedure 4 weeks later
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Serge A Steenen
- CONTACT for SCIENTIFIC QUERIES Serge A Steenen
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
None
- PublicationsBrunet A, Orr SP, Tremblay J, Robertson K, Nader K, Pitman RK: Effect of post-retrieval propranolol on psychophysiologic responding during subsequent script-driven traumatic imagery in post-traumatic stress disorder. J Psychiatr Res 2008, 42:503–6. Lonergan MH, Olivera-Figueroa LA, Pitman RK, Brunet A: Propranolol’s effects on the consolidation and reconsolidation of long-term emotional memory in healthy participants: a meta-analysis. J Psychiatry Neurosci 2013, 38:222–31.
- Brief summaryBackground: Tooth and molar removals are among the most strongly feared procedures in dentistry and oral and maxillofacial surgery. Fear of extractions not only produces discomfort to the patient, but may also induce patient behavior that impedes surgery, thereby increasing operative time and complicating postoperative recovery. In addition, it has been found that undergoing an extraction poses a significantly increased risk for the development of chronic apprehension for dental surgical procedures, disproportionate forms of dental anxiety (i.e., dental phobia), and symptoms of post-traumatic stress. Evidence suggests that intrusive emotional memories of these events both induce and maintain these forms of anxiety. Addressing these problems effectively requires an intervention that durably reduces both the intrusiveness of key fear-related memories, and state anxiety during surgery. There is evidence to suggest that propranolol is capable of inhibiting “memory reconsolidation” (i.e., to block the process of storing a recently retrieved fear memory). Hence, the purpose of this trial is to determine the anxiolytic and fear memory reconsolidation inhibiting effects of the ß-adrenoreceptor antagonist propranolol on patients with high levels of fear in anticipation of a dental extraction.

Methods: Trial design: Multicenter, randomized, placebo-controlled, two-group, parallel, double-blind trial of 34 participants. Population and recruitment: Consecutive patients, referred by their dentist to the departments of oral and maxillofacial surgery of a University hospital and a secondary referral hospital in the Netherlands, for at least two tooth and/or molar removals, with self-reported high to extreme fear in anticipation of a dental extraction. Intervention: Two 40 mg propranolol capsules one hour prior to a dental extraction, followed by one 40 mg capsule directly postoperatively. Comparator: Placebo capsules. Primary outcome: Dental trait anxiety score reduction from baseline to 4-weeks follow-up. Secondary outcomes: Self-reported anxiety during surgery; physiological parameters (heart rate and blood pressure) during recall of the crucial fear-related memory; self-reported vividness and emotional charge of the crucial fear-related memory.

Discussion: This randomized trial is the first to test the efficacy of 120 mg of perioperative propranolol versus placebo in reducing short-term (‘state’) anxiety during dental extraction, fear memory reconsolidation, and lasting dental (‘trait’) anxiety in a clinical population. If the results show a reduction in anxiety, this would offer support for routinely prescribing propranolol in patients who are highly fearful of undergoing a dental extraction.
- Main changes (audit trail)
- RECORD16-aug-2015 - 6-okt-2015


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