The effect of Marinol (tetra-9-hydrocannabinol) on the frequency of TLESRs.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON21968

Enrollment

Registered

2005-05-31

Start date

2004-05-03

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Twice a 4 hours esophageal manometry and pH-metry (transnasally). Single dose of 10mg marinol (delta-9-hydrocannabinol, THC) and a single dose of placebo.

Eligibility

Inclusion criteria

Inclusion criteria: 1. Man, 2. 18-55 years, 3. 65-100kg, 4. bmi 19-30 kg/m2, 5. normal fysical and laboratorial findings at start of study.

Exclusion criteria

Exclusion criteria: 1. Clinical relevant illness two weeks prior to start of study; 2. systemic illness which influence esophageal motility; 3. use of drugs that influence gastrointestinal motility; 4. drug abuse, 5. mania, depression, schizofrenia or another mental illness; 6. cardiac complaints as hypo-. hypertension, syncope, tachycardia; 7. cannabis allergy, 8. sesame oil allergy or another severe allergy.

Design outcomes

Primary

Measure	Time frame
Frequency of transient lower esophageal sfincter relaxations (TLESRs) measured by esophageal manometry up to 3hours postprandially.	—

Secondary

Measure	Time frame
Rate of acid reflux episodes measured with pH-metry for 3 hours postprandially, basal lower esophageal sphincter pressure (LESp) measured by manometry.	—

Contacts

Public ContactG.E.E. Boeckxstaens

Academic Medical Center (AMC), Department of Gastroenterology, C2-328, P.O. Box 22660

g.e.boeckxstaens@amc.uva.nl+31 (0)20 5667375

Outcome results