Table 2.
Study ID | Year | Journal | Pubmed ID | Trial registry ID |
---|---|---|---|---|
Abrams 2007 | 2007 | Neurology | 17296917 | NCT00046722 |
Population | 55 HIV + adults with symptomatic
HIV-DSPN and at least 30/100 VAS, on stable pain regimen for 8 weeks prior to enrolment, with prior experience of smoking cannabis randomized in 2 groups of size: 27/28. Our Bayesian analysis is based on 50 participants with one observation per patient, as provided by the primary study authors. Age (Experimental, Control): 50 years (SD ±6)), 47 (SD ± 7) Gender (male/female/other): Experimental 22/5/0 Control 26/2/0 |
|||
Intervention |
Experimental: Patient
smoked one cigarette three times per day as tolerated Pre-rolled, whole herb Cannabis cigarettes were provided by NIDA and contained 3.56% delta-9-THC. Control: identical pre-rolled cigarettes with the active ingredient extracted. Dose estimate: 32 mg THC per session; 96 mg THC per day |
|||
Primary Outcome | Daily pain diary recording the VAS
at 8am for average pain during the previous 24 hours. |
|||
Study Methods | Randomized, double-blind (patient,
outcome assessor), parallel design, placebo controlled, single center (university) clinical trial in San Francisco, California, USA starting in 2003 |
|||
Notes | Also published as an abstract at
the 2nd Annual meeting of the International Association for Cannabis as Medicine, 2005 Secondary outcomes: Acute analgesic effects: Long thermal stimulation Anti-hyperalgesic effects: Heat-capsaicin model, Profile of Mood States |
|||
Study ID | Year | Journal | Pubmed ID | Trial registry ID |
Ellis 2009 | 2008 | Neuropsychopharmacology | 18688212 | NCT00255580 |
Population | 34 HIV + adults with symptomatic
HIV-DSPN and pain score >5/20 on DDS (Discriptor Differential Scale), most participants were previously exposed to potentially neurotoxic deoxy-nucleoside reverse transcriptase inhibitors; 16 started control/experimental, 18 started experimental/control. 28 participants with a total of 56 observed responses were included in the Bayesian analysis. Age (all) 49.1 years (SD ±6.9)), Gender (male/female/other): 33/1/0 |
|||
Intervention |
Experimental: Patient
smoked cannabis, titrating dose up or down to effective pain control/ tolerable adverse effects, starting at 4 percent to range between 1 to 8 percent delta-9-tetrahydrocannabinol (THC) concentration by weight. Pre-rolled, whole herb Cannabis cigarettes were provided by the National Institute on Drug Abuse. Control: identical pre-rolled cigarettes with the active ingredient extracted. Dose estimate: average 96 mg THC per day |
|||
Primary Outcome | Crossover difference in change of
DDS (Descriptor Differential Scale 0-20 scale “a ratio scale containing 24 words describing pain intensity and unpleasantness.”) comparing baseline to after treatment |
|||
Study Methods | Randomized, double-blind (patient,
outcome assessor), cross-over design, placebo controlled, single center (university) clinical trial at the University of California, San Diego in 2006 |
|||
Notes | Secondary outcomes: McGill
Questionaire, VAS, SIP (Sickness Impact Profile), BSI (Brief Symptom Inventory), UKU side effect rating, Highness/Sedation Scale, HIV load |
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Study ID | Year | Journal | Pubmed ID | Trial registry ID |
Ware 2010 | 2010 | Canadian Medical Association Journal |
20805210 | ISRCTN68314063 |
Population | 23 adults with non HIV neuropathy
pain of at least 3 months duration caused by trauma or surgery defined by pain intensity score greater than 40/100 VAS, on a stable analgesic regimen, not having smoked cannabis in the preceding year. 23 participants with a total of 86 observed responses were included in the Bayesian analysis. Age (all): 45.4 years (SD ±12.3) Gender (male/female/other): 11/12/0 |
|||
Intervention |
Experimental: NIDA
and Prairie plant systems prepared three different potencies of THC (2.5%, 6%, 9.4%) from whole herb in gelatine capsules inhaled through pipe. Control: Ethanolic extraction was used to prepare the placebo. Dose estimate: 0, 1.625, 3.9 and 5.85 mg/day (average) THC per period |
|||
Primary Outcome | Average Daily Pain Intensity on
the 11-item numeric rating scale (NRS) average over five treatment days (least pain value, average pain value and worst pain value) during four consecutive crossover periods of 14 days each (five treatment days and 9 washout days afterwards) |
|||
Study Methods | Randomized, double-blind (patient,
outcome assessor), 4 period crossover Latin square design, placebo controlled, single center (university) clinical trial in McGill University, Montreal, Canada, starting in 2003 |
|||
Notes | The linear model did not consider
inter participant effect. Secondary outcomes: Pain Quality: McGill Questionaire, Sleep (Leeds Sleep Evaluation Questionaire), Mood Effects: short-form Profile of Mood States, Quality of Life: EQ-5D health outcomes |
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Study ID | Year | Journal | Pubmed ID | Trial registry ID |
Wilsey 2008 | 2008 | The Journal of Pain | 18403272 | NCT00254761 |
Population | 38 adults with non HIV neuropathy
(complex regional pain syndrome (CRPS type I), spinal cord injury, peripheral neuropathy, or nerve injury) with prior cannabis experience and a VAS > 30/100. 38 participants with 102 observed responses were included in the Bayesian analysis. Age (all): 46 years (range 21-71) Gender (male/female/other): 20/18/0 |
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Intervention |
Experimental
Participants inhaled a total of 9 standardized cued-puff.
Cannabis was harvested from whole plant and rolled into cigarettes at the U of Mississippi under supervision of NIDA ranging in strength from 0%, 3.5% to 7%. Control: Placebo Cigarettes were made from whole plant with extraction of Cannabis. Dose estimate: 0 Placebo, 19.25 (low dose, range 7-30.45), 34.3 (high dose, range 18.9-60.9) mg THC/day (Session) |
|||
Primary Outcome | VAS measuring spontaneous pain
relief; time effects were studied with a linear model. |
|||
Study Methods | Randomized, double-blind (patient,
outcome assessor), parallel design, placebo controlled, single center (university) clinical trial at UC Davis Medical Center Sacramento, California started in November 2003 |
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Notes | Secondary outcomes: pain
unpleasantness (VAS), heat pain threshold, Neuropathic Pain Scale, Neurocognitive assessment and plasma Cannabis concentration |
|||
Study ID | Year | Journal | Pubmed ID | Trial registry ID |
Wilsey 2013 | 2013 | The Journal of Pain | 23237736 | NCT01037088 |
Population | 39 adults with non HIV neuropathy
due to reflex sympathetic dystrophy, peripheral neuropathy, post-herpetic neuralgia, post-stroke pain, multiple sclerosis or spinal cord injury with previous cannabis exposure (16 current, 23 ex-users) and a VAS pain intensity greater than 30/100. 39 participants with 111 observed responses were included in the Bayesian analysis. Age (all): 50 years (SD ±11)) Gender (male/female/other): 28/11/0 |
|||
Intervention |
Experimental:
Participants used a volcano vaporizer under the flexible-dose
design of Wilsey 2008. The minimum and maximum cumulative doses for each visit were 8 and 12 puffs. Cannabis was harvested at the University of Mississippi under the supervision of NIDA. Control: Placebo was made from whole plant with removal of cannabinoids. Dose estimate: Maximum of 0, 10.32, 28 mg THC/day (Session), presuming they were administered the entire 800 mg dose. |
|||
Primary Outcome | VAS before and after consuming vaporized cannabis. | |||
Study Methods | Randomized, double-blind (patient,
outcome assessor), crossover design, placebo controlled, single center (university) clinical trial at the University of California, Davis, started December 2009 |
|||
Notes | Secondary outcomes: Patient Global
Impression of Change (PGIC); Neuropathic Pain Scale (NPS); WAIS-III, Hopkins Verbal Learning Test (revised), Grooved Pegboard Test |
We provide detailed characteristics of the five included randomized controlled clinical trials investigating smoked or inhaled cannabis for painful neuropathy. Two trials recruited patients with HIV related Distal Sensory Polyneuropathy (HIV DSPN), three included participants with neuropathies of other etiologies. (VAS Visual Analogue Scale; SD Standard deviation; NA not available; NIDA US National Institute of Drug Abuse)