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Nabiximols Plus Counseling Cuts Cannabis Use in Dependent Patients

July 16, 2019

By Reuters Staff

NEW YORK (Reuters Health) - Treatment with the cannabis extract nabiximols (Sativex), along with psychosocial interventions, can reduce cannabis use in dependent individuals, new research in the Annals of Internal Medicine shows.

"Although further research is required to replicate our findings and to refine how cannabinoid agonist treatment is delivered, our study suggests cannabinoid agonist treatment to be a promising approach for treating patients with cannabis dependence, particularly for those who cannot sustain reductions in illicit cannabis use with counseling-only interventions, in a stepped care approach," Dr. Nicholas Lintzeris of South East Sydney Local Health District in New South Wales, Australia, and colleagues from the Agonist Replacement for Cannabis Dependence study group conclude.

About 80% of patients with cannabis dependence return to regular use within a few months after withdrawal or counseling interventions, Dr. Lintzeris and his team note in their July 15 report. Cannabinoid agonists are effective for easing symptoms of acute cannabis withdrawal, they add, but high relapse rates mean longer treatment may be necessary. A recent pilot study found 12 weeks of treatment with nabiximols, a cannabis extract in oral spray form containing tetrahydrocannabinol (THC) and cannabidiol (CBD), helped patients reduce cannabis use.

The authors randomly assigned 128 patients at four alcohol and drug treatment clinics to receive 12 weeks of treatment, which included weekly clinical reviews, counseling and flexible doses of nabiximols or placebo. Study participants could self-administer up to 32 sprays daily (84.6 mg THC and 80 mg CBD), and medication was dispensed weekly.

Study participants had used a mean 2.3 g of cannabis on 25.7 of the previous 28 days. Thirty patients in each group (44.8% of placebo group, 49.2% of nabiximols group) completed the study.

The placebo group used a mean 18.5 doses per day and the nabiximols group used 17.6 doses daily, equivalent to about 45.7 mg of THC and 44.0 mg CBD.

Over the study period, placebo group patients used cannabis on 53.1 days, on average, compared to 35 days for the nabiximols group, an estimated difference of 18.6 days. At least one four-week period of abstinence was achieved by 18.2% of the placebo group and 26.5% of the nabiximols group, while 28.9% of placebo group patients reduced their cannabis use by at least half from baseline, versus 54.1% of the nabiximols group (odds ratio 0.35, number needed to treat four).

Adverse event rates were similar for both groups. Aberrant medication behaviors, such as giving away or selling medication or changing medication dose, were reported by 21.1% of patients on nabiximols and 37.8% of the placebo group.

Most study participants (74.5% of placebo group, 82.4% of the nabiximols group) said they would recommend the treatment to a friend.

"The reductions in illicit cannabis use, and a safer route of administration (compared with smoked cannabis using bongs or joints that are associated with chronic respiratory problems) suggest the harm reduction benefits of cannabinoid agonist treatment," Dr. Lintzeris and colleagues write.

However, the authors add, high drop-out rates from both study screening and treatment suggests the cannabinoid agonist treatment "is unlikely to be an approach relevant to all cannabis users seeking treatment."

They conclude: "Whereas nicotine-agonist and opioid-agonist treatments are considered front-line therapies, our findings suggest a more cautious approach for cannabinoid agonist treatment at this time."


JAMA Intern Med 2019.

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