Table 2.
Summary of dronabinol studies.
| First Author, Year | Country | Study Drug | Posology | Duration | Enrolled Patients | Patients Who Have Completed the Trial | Mean Age [yrs (SD)] | Sex [M/F (N)] | Outcomes | Reported Adverse Events |
|---|---|---|---|---|---|---|---|---|---|---|
| Malik, 2007 | USA | dronabinol | 5 mg bid for 4 weeks | 4 weeks | 19 | 13 | placebo: 42 (ND) active: 44 (ND) |
2/11 | Effect of dronabinol on pain threshold, frequency, and intensity in functional chest pain (FCP) | Loose stools, nausea, headache, fatigue |
| Schimrigk, 2017 | Germany | dronabinol | titration to daily doses 7.5–15.0 mg | 16 weeks | 240 | 169 | placebo: 47 (9.7) active: 48.4 (9.6) |
65/175 | Positive benefit–risk ratio of dronabinol in the treatment of neuropathic pain in MS patients |
Insomnia, Nausea, Dizziness, Vertigo, Headache, Fatigue, Dry mouth |
| van den Elsen, 2015 | The Netherlands | dronabinol | 1.5 mg tid for 3 weeks | 3 weeks | 50 | 50 | placebo: 78 (7) active: 79 (8) | 25/25 | Efficacy and safety of THC in the treatment of dementia-related neuropsychiatric symptoms (NPS) | Delirium, Cognitive disorder, Euphoric mood, Bradykinesia, Somnolence, Agitation, Nasopharyngitis, Pneumonia, COPD, Back pain, Muscle weakness, Muscle spasms, Pain in extremity, Renal impairment, Urge incontinence, Dry eye, Eye hemorrhage, Miosis, Balance disorder, Chest pain, Skin disorder, not otherwise specified, Dizziness, Sensory loss, Restlessness, Aphasia, Apraxia, Headache, Fatigue, Malaise, Presyncope, Syncope, Decreased appetite, Increased gamma-glutamyl transferase, |
| Ahmed, 2014 | The Netherlands | dronabinol | 3–6.5 mg | 6 weeks | 12 | 11 | placebo & active: 72.1 (5) | 6/6 | Safety and tolerability effects of THC in elderly | Euphoria, Concentration problem, Visual hallucination, Relaxation, Dry eye, Blurred vision, Nausea, Coordination disturbance, Drowsiness, Dizziness, Headache, Malaise, Dry mouth |
| Wong, 2012 | USA | dronabinol | 2.5 or 5 mg bid | 2 days | 36 | 36 | placebo: 36.7 (3.1) active (2.5 mg): 47.7 (7.9) active (5 mg): 42.3 (4.5) | 2/34 | Gut transit in IBS-D and dronabinol’ transit effect | “Loopy”, foggy thinking, Hot flushes, Drowsiness/Tiredness, Dizziness/Light-headedness, Headache |
| Brisbois, 2011 | Canada | dronabinol | 2.5 mg bid (patients had the option to increase their drug dose to a maximum of 20 mg/day) | 3 weeks & 1 day | 46 | 21 | placebo: 65.5 (8) active: 67 (10.9) | 12/9 | Effects of THC on chemosensory perception | Confusion, Seizure, Troubles sleeping, Pneumonia, Thrush, Stomach cramps, Bowel obstruction/constipation, Diarrhea, Vaginal discharge, Unsteady feet, Shortness of breath/fluid on lungs, Nausea/Vomiting, Hives/Rash, Fever, Headache, Pain, Tired/Drowsy, Oedema, Low blood count |
| Esfandyari, 2006 | USA | dronabinol | 5–7.5 mg bid | 2 days | 30 | 30 (27) (3 patients did not complete the study; however, their missing data is included in the ITT analysis) |
placebo: 29 (1) active: 26 (2) | 14/16 | Effect of dronabinol of gastrointestinal transit and postprandial satiation | Excitement, Euphoria/Relaxed, Disturbed mental concentration, Nausea, Numbness, Flushing, Drowsiness, Dizziness/Light-headedness, Headache, Vasovagal, Dry mouth |
| Svendsen, 2004 | Denmark | dronabinol | titration to 5 mg bid | 3 weeks | 24 | 24 | placebo & active: 50 (median) | 10/14 | Effect of dronabinol on central neuropathic pain in MS patients | Euphoria, Feeling of drunkenness, Speech disorders, Hyperactivity, Nervousness, Aggravated MS, Migraine, Sleep difficulty, Upper airway infection, Muscle weakness, Myalgia, Hot flushes, Diplopia, Balance difficulty, Palpitations, Abdominal pain, Nausea, Drowsiness, Dizziness, Fever, Headache, Fatigue, Anorexia, Weight decrease, Dry mouth, Chills |
| Zajicek, 2003 | UK | dronabinol | 2.5 mg | 15 weeks | 419 | 404 | placebo: 50.9 (7.6) active: 50.2 (8.2) | 141/278 | Effect of cannabinoids on spasticity and other symptoms in MS patients | Bladder, Depression of anxiety, Dizzy of light-headedness, Dry mouth, Gastrointestinal tract, Improvement in symptoms, Infection, Miscellaneous, Numbness of paresthesia, Pain, Sleep, Spasms of stiffness, Tremor of lack of coordination, Vision, Weakness of reduced mobility |
| Killestein, 2002 | The Netherlands | dronabinol | 2.5–5 mg bid | 4 weeks | 16 | 16 | placebo & active: 46 (7.9) | no data | Efficacy, safety, and tolerability effects of THC in MS patients | Emotional lability, Ataxia, Somnolence, Increased spasticity, Dizziness, Headache, Dry mouth, Other |
F: female, M: male, ND: no data, yrs: years, bid: twice a day, tid: three times daily.