One dose of dronabinol 2.5 mg was taken orally with water.

One dose of dronabinol 5 mg was taken orally with water.

One dose of placebo was taken orally with water.

One dose of dronabinol 2.5 mg will be taken orally with water.

Dronabinol 2.5 mg

One dose of dronabinol 5 mg will be taken orally with water.

Dronabinol 5 mg

One dose of placebo will be taken orally with water.

Placebo

Total

Sex: Female, Male

Region of Enrollment

Body Mass Index

Colonic compliance is a measure of the "stiffness" of the colon, that is, what pressure was needed to reach half the maximum volume of the colon.
After the barostat catheter was inserted in the colon, the catheter was connected to a barostat machine. After an initial conditioning distension to 20 mm Hg, colonic compliance was measured by step-wise inflation with increments of 4 mm Hg up to 64 mm Hg. Colonic compliance was analyzed by a validated linear interpolation method. The pressure at half maximum volume serves as a summary of colonic compliance.

Colonic Compliance at Pressure at Half-Maximum Volume (Pr 1/2)

Colonic tone is a measurement of the volume of the colon. Colonic tone was assessed by noting the changes in the balloon volume in the presence of a constant operating pressure in the balloon (in the barostat-manometric assembly placed in the colon.)

Postprandial Change in Colonic Tone

The sensory threshold for first perception of pain was measured by stepwise inflation in increments of 4 mm Hg at 60 second intervals up to a maximum pressure of 64 mm Hg. During this assessment participants were asked to report when they had the first sensation. The investigator recorded the threshold pressure at which the participants reported this sensation.

Post-treatment Sensory Threshold for First Perception of Pain

The sensory rating was measured by a 100 mm long Visual Analog Scale (VAS). The VAS does not have any pre-set marks between the extremes of 0 for no pain and 100 mm for extreme pain. The investigator measures the mark made by the participant in mm and records this for the value of pain.

Post-Treatment Overall Sensory Rating in Response to 16, 24, 32, and 40 mm Hg Distensions

Fasting Colonic Tone

Colonic phasic pressure activity is summarized as a motility index (MI)=log_e[number of contractions * sum of amplitudes) + 1]. A normal fasting average motility index (MI) would be about 12. An increase in MI means an increase in the phasic contractions (in contrast to tone) which is measured as a change in volume of the barostat balloon. (Therefore, an increase in MI means that the meal is moving more quickly through the colon.)

Postprandial Colonic Motility Index

The sensory threshold for first sensation was measured by stepwise inflation in increments of 4 mm Hg at 60 second intervals up to a maximum pressure of 64 mm Hg. During this assessment participants were asked to report when they had the first sensation. The investigator recorded the threshold pressure at which the participants reported this sensation.

Post-treatment Sensory Threshold for First Sensation

The sensory threshold for first perception of gas was measured by stepwise inflation in increments of 4 mm Hg at 60 second intervals up to a maximum pressure of 64 mm Hg. During this assessment participants were asked to report when they had the first sensation. The investigator recorded the threshold pressure at which the participants reported this sensation.

Post-Treatment Sensory Threshold for First Perception of Gas

Overall Study

Dr. Michael Camilleri

Irritable Bowel Syndrome

Dronabinol is a synthetic delta-9-tetrahydrocannabinol, a nonselective cannabinoid agonist. Subjects received one dose of either 2.5 mg or 5 mg orally with water.

Dronabinol

Placebo will match study drug; taken as one dose orally with water.

Link to Part A of this study, results for GI and colonic motor functions, n=36

Mayo Clinic

Effect of a Cannabinoid Agonist on Colonic Sensory Functions in Patients With Irritable Bowel Syndrome

Study on the Effect of Cannabinoid Agonist on Gastrointestinal and Colonic Motor and Sensory Functions in Patients With Diarrhea-Predominant Irritable Bowel Syndrome

Michael Camilleri

Professor of Medicine

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

National Center for Research Resources (NCRR)

Marinol

Number of people still experiencing the same amount of chest pain during treatment than previously without

Frequency of Chest Pain Episodes

Total (intensity (0(none) - 3(severe) + duration (0(none) - 3(longer than 30 mins)) at end of 1 month treatment; higher represents worse outcome; the total score ranges from 0 to 6 and is the sum of the intensity and duration

Frequency of Chest Pain in Treatment Group vs Baseline

Intensity (0(none) - 3(severe)) at baseline vs 1 month for chest pain episodes; higher represents worse outcome; multiple chest pain totals are averaged

Intensity of Chest Pain Episodes

This is determined by the Esophageal Balloon Distension Test; range 0-65 mmHg

Sensory Thresholds for First Sensation

0 - is none and 3 is longer than 30 mins; higher values is worst outcome; chest pain totals are averaged

Duration of Chest Pain Episodes

When participants felt pain at earliest pressure; range 0-65 mmHg

Sensory Thresholds for Discomfort

When highest amount of pain was felt; range is 0-65 mmHg

Sensory Thresholds for Pain

Dr. Ron Schey

Chest Pain

University of Iowa Hospitals and Clinics

The Effects of Cannabinoid on Patients With Non-GERD Related Non Cardiac Chest Pain

Yehudith Assouline-Dayan

Clinical Assistant Professor

Dronabinol 2.5 mg will be taken orally with water twice per day for two days.

Dronabinol 5 mg will be taken orally with water twice per day for two days.

Placebo will be taken orally with water twice per day for two days.

Dronabinol 2.5 mg Bid

Dronabinol 5 mg Bid

Body Mass Index (BMI)

The scintigraphic method is used to measure colonic transit. An isotope is adsorbed on activated charcoal particles and delivered to the colon in a delayed release capsule. Anterior and posterior gamma images are taken hourly. The geometric center (GC) is the weighted average of counts in the different colonic regions. The scale ranges from 1 to 5; a high GC implies faster colonic transit, a GC of 1 implies all isotope is in the ascending colon, and a GC of 5 implies all isotope is in the stool.

Colonic Transit Geometric Center

The time for half of the ingested solids or liquids to leave the stomach.

Gastric Emptying Half-Time (t1/2)

Percent of the radio-labeled meal that reached the colon at 6 hours, indirectly reflecting small bowel transit time.

Colonic Filling at 6 Hours

Ascending colon emptying t1/2 will be estimated by power exponential analysis of the proportionate emptying over time of counts from the colon. The primary data for this analysis will be the proportion of decay and depth-corrected counts in the ascending colon on the hourly scans on the first day of transit measurement and the 48 hour data.

Ascending Colon Emptying T 1/2

Proportion of stomach contents emptied at a 2 and 4 hours.

Gastric Emptying at 2 and 4 Hours

Colonic Transit Geometric Center at 24 Hours

Dronabinol is a synthetic delta-9-tetrahydrocannabinol, a nonselective cannabinoid agonist. Subjects will receive either 2.5 mg bid, or 5 mg bid, taken orally with water for 2 days.

Placebo will match study drug; taken orally with water twice per day for two days.

diarrhea/cannabis

Effect of a Cannabinoid Agonist on Colonic Sensory Functions in Patients With Irritable Bowel Syndrome

The Effects of Cannabinoid on Patients With Non-GERD Related Non Cardiac Chest Pain

Effect of Cannabinoid Agonist on Gastrointestinal and Colonic Motor Functions in Patients With Irritable Bowel Syndrome (IBS)

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