Placebo-controlled, Double Blind Trial of Medicinal Cannabis in Painful HIV Neuropathy

INVESTIGATOR: Ronald Ellis, M.D., Ph.D.

STUDY LOCATION: University of California, San Diego

PROJECT TITLE: Placebo-controlled, Double Blind Trial of Medicinal Cannabis in Painful HIV Neuropathy

PROJECT TYPE: Clinical Study

STATUS: COMPLETE

RESULTS:

Of 127 volunteers screened, 34 eligible subjects enarolled and 28 completed both cannabis and placebo treatments. Among completers, pain relief was greater with cannabis than placebo (median difference in DDS pain intensity change, 3.3 points, effect size = 0.60; p = 0.016). The proportions of subjects achieving at least 30% pain relief with cannabis versus placebo were 0.46 [95% CI 0.28, 0.65] and 0.18 [0.03, 0.32]. Mood and daily functioning improved to a similar extent during both treatment periods. Although most side effects were mild and self-limited, two subjects experienced treatment-limiting toxicities.

Smoked cannabis was generally well-tolerated and effective when added to concomitant analgesic therapy in patients with medically refractory pain due to HIV DSPN.

The full results of this study were published in the journal Neuropsychopharmacology.

ABSTRACT:

Neuropathic pain continues to be a major clinical problem in HIV infection. The predominant cause is an axonal polyneuropathy, termed HIV-associated distal, sensory-predominant polyneuropathy (DSPN) that is variably associated with HIV itself or with the use of certain nucleoside analogue HIV reverse transcriptase inhibitors used in antiretroviral treatment regimens. Available treatments, including opioids and adjunctive pain-modulating agents, often are ineffective for pain control, resulting in disability and diminished quality of life for individuals with HIV infection. The proposed study will be a double-blind, placebo-controlled trial of medicinal cannabis for the short-term adjunctive treatment of neuropathic pain in HIV-associated DSPN. Case ascertainment will be by history, physical examination, nerve conduction studies and quantitative sensory testing. Thirty subjects will be enrolled in a double-blind, cross-over trial design. Because a safe and effective dosing range for cannabis for neuropathic pain has not been previously established, and because we anticipate that the frequency and magnitude of both beneficial antinociceptive and adverse drug effects with cannabis will differ substantially across individuals, a structured dose escalation-titration protocol will be used to find an individualized, effective, safe and well-tolerated and dose for each subject. The total study duration will be 3 years. The principal outcome measures will be changes in self-reported pain, disability in activities of daily living and indices of quality of life.

PUBLICATIONS:

Type:

Title:

Journal Article Ellis RJ, Toperoff W, Vaida F, van den Brande G, Gonzales J, Gouaux B, Bentley H, Atkinson JH. (2009). Smoked Medicinal Cannabis for Neuropathic Pain in HIV: A Randomized, Crossover Clinical Trial. Neuropsychopharmacology. 2009 Feb;34(3):672-80. doi: 10.1038/npp.2008.120. Epub 2008 Aug 6.

Study to Examine Possible Effects of Cannabis Compound for Common Movement Disorder

Press Release, UC San Diego Health, September 18, 2018

Researchers at University of California School of Medicine are preparing to launch a novel clinical trial to examine the safety, efficacy and pharmacological properties of cannabis as a potential treatment for adults with essential tremor (ET). Currently, ET is treated using repurposed medications originally developed for high blood pressure or seizures. Surgery is another option.

Scheduled for early 2019, the phase I/II trial will assess efficacy and tolerability of an oral cannabis formulation comprised of cannabidiol (CBD) and low-dose tetrahydrocannabinol (THC). Researchers say it will be the first time this combination has been studied for treatment of ET.

“This study will provide key insights,” said Fatta Nahab, MD, neurologist at UC San Diego Health and associate professor of neurosciences at UC San Diego School of Medicine. “If found to be safe and effective, cannabis would not only serve as an exciting new addition to the limited treatment options currently available for patients with ET, but it might also provide scientists with new insights on essential tremor.”

Read the full press release here


Cannabis for Chronic Nerve Pain: Mechanism Revealed?

Damian McNamara, Medscape, September 7, 2018

New imaging findings show how tetrahydrocannabinol (THC), the psychoactive component of cannabis, works in the brain to effectively treat chronic neuropathic pain.

Results of a small randomized, double-blind, crossover trial show that THC-induced pain relief was associated with reduced functional connectivity between the anterior cingulate cortex (ACC) and the sensorimotor cortex.

"The main message of this paper is that THC, the psychoactive component in cannabis, does seem to exert a beneficial effect on proven chronic nerve pain.

This effect seems to involve a breakdown in functional connectivity between brain regions that process different dimensions that construct the experience of pain," study author Haggai Sharon, MD, who leads the Consciousness & Psychopharmacology research team at Sagol Brain Institute, Tel Aviv, Israel, told Medscape Medical News.

Read the article here


Cannabis Compound May Help Reduce Symptoms of Psychosis

Bob Curley, Healthline, September 5, 2018

Chronic marijuana use has been linked to increased risk of psychiatric problems. There’s even a name for the condition — cannabis-induced psychosis (CIP).

A new study, however, shows that a nonpsychoactive compound found in cannabis seems to reduce abnormal brain functions associated with psychosis, which includes diseases such as schizophrenia and bipolar disorder.

Researchers at King’s College London report in the journal JAMA Psychiatry that a single dose of cannabidiol (CBD) could someday be an effective alternative to the antipsychotic drugs in use since the 1950s.

These include Thorazine and Haldol, which have limited effectiveness and can cause serious side effects.

“It’s clear that the existing drugs have provided a lot of patients with schizophrenia the ability to function in society, but they’re not a cure,” Dr. Igor Grant, chair of the department of psychiatry at the University of California at San Diego School of Medicine and director of the school’s Center for Medicinal Cannabis Research, told Healthline.

Read the story here


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