Tetrahydrocannabinol Does Not Reduce Pain in Patients With Chronic Abdominal Pain in a Phase 2 Placebo-controlled Study Marjan de Vries, Dagmar C.M.

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Tetrahydrocannabinol Does Not Reduce Pain in Patients With Chronic Abdominal Pain in a Phase 2 Placebo-controlled Study Marjan de Vries, Dagmar C.M. van Rijckevorsel, Kris C.P. Vissers, Oliver H.G. Wilder-Smith, Harry van Goor Clinical Gastroenterology and Hepatology Volume 15, Issue 7, Pages 1079-1086.e4 (July 2017) DOI: 10.1016/j.cgh.2016.09.147 Copyright © 2017 AGA Institute Terms and Conditions

Figure 1 Mean VAS pain at baseline (days –5 to –1) and during study treatment (days 1–49) for THC and placebo in patients with chronic abdominal pain (n = 50), subdivided into CP (n = 23) and PSP (n = 27). VASpain scores are shown until day 49, which is the last day of diary for most patients. Gray bars represent baseline period. Clinical Gastroenterology and Hepatology 2017 15, 1079-1086.e4DOI: (10.1016/j.cgh.2016.09.147) Copyright © 2017 AGA Institute Terms and Conditions

Supplementary Figure 1 After baseline measurements, patients were administrated 3 mg TID THC or placebo from days 1 to 5. On day 5, tolerability was evaluated. Dosage of days 6–10 was increased to 5 mg TID, or when not tolerated, the patient was withdrawn. On day 10, the tolerability was evaluated again. From days 11 to 15, dosage was further increased to 8 mg TID. This dosage could be tapered to 5 mg TID when 8 mg appeared to induce unacceptable AEs (dotted arrows). At day 15 the tolerability was evaluated again. If tolerable, patients proceeded with 8 mg TID, but if not, dosage was reduced to 5 mg TID. Gray-filled arrows represent decision points I and II: increased dosage or withdrawal. Black-filled arrow represents decision point III: continue 8 mg TID, taper to 5 mg TID, or withdrawal. Dotted line represents the permitted dose adjustment of minimal 5 mg TID. Clinical Gastroenterology and Hepatology 2017 15, 1079-1086.e4DOI: (10.1016/j.cgh.2016.09.147) Copyright © 2017 AGA Institute Terms and Conditions

Supplementary Figure 2 CONSORT flowchart. Clinical Gastroenterology and Hepatology 2017 15, 1079-1086.e4DOI: (10.1016/j.cgh.2016.09.147) Copyright © 2017 AGA Institute Terms and Conditions

Supplementary Figure 3 Mean (unilateral SD error bars) plasma concentration curves of THC and 11-OH-THC obtained after 50–52 treatment days in chronic abdominal pain subjects taking 5 mg versus 8 mg TID THC. Clinical Gastroenterology and Hepatology 2017 15, 1079-1086.e4DOI: (10.1016/j.cgh.2016.09.147) Copyright © 2017 AGA Institute Terms and Conditions