First study of its kind finds counterintuitive use for prescription CBD


As of now, there are no scientifically approved treatments for cannabis use disorder, a problem for those struggling with drug dependence. The need is there: Studies indicate that 47 percent of people who stop using marijuana experience withdrawals, while other research suggests that 9 percent of people who use marijuana will become dependent on it.

However, a solution could be on the horizon. In a recent double-blind randomized controlled trial, researchers found that cannabidiol (CBD), a chemical compound found in cannabis, can actually help people quit smoking.

The study team found that prescription-grade CBD moderately reduced cannabis intake and helped people refrain from using cannabis more than a placebo treatment. Prescribed CBD is typically more than 16 times stronger than commercially available CBD.

“There are currently no safe and effective prescription treatments available to help people with cannabis use problems,” says study co-author Tom Freeman, a psychopharmacology researcher at the University of Bath. Reverse. “This is a large and unmet clinical need and could help people quit smoking in an acceptable treatment format.”

If other studies confirm these findings, CBD can become a vital tool for the 22 million people who face this distressing and life-altering problem.

The findings were published Tuesday in the journal. Lancet Psychiatry.

The experiment – To determine if CBD is safe and could help people with cannabis use disorder, the researchers recruited 82 people diagnosed with the disorder with cases that were considered at least moderately severe.

This means that they experienced at least four of the 11 possible addiction symptoms, including:

  • Continued substance use despite having a persistent or recurring social or interpersonal problem caused or exacerbated by the effects of the substance
  • A great deal of time is spent in activities necessary to obtain the substance, use it, or recover from the effects.

“Most people who use cannabis do so without significant problems,” Freeman explains. “Others find that it has a substantial negative impact on their lives, such as their ability to work, their relationships with friends and family, and their mental and physical health.”

Study participants recognized that their cannabis use was interfering with an optimal life and wanted to reduce their use. Each participant expressed a desire to quit smoking next month, cut marijuana with tobacco, and had tried to quit using cannabis on at least one occasion before.

Participants were randomly assigned to treatment groups and asked to take two prescription CBD capsules twice daily for four weeks. The placebo group received simulated capsules that did not contain CBD, while the others received a daily dose of 200 mg, 400 mg or 800 mg of CBD.

All participants received six counseling sessions designed to help them stop using cannabis, which took place before and during the study period.

Throughout the study, the researchers analyzed the participants’ urine weekly for THC to assess the amount of cannabis that had been consumed last week. Participants were also asked to report how many days they had abstained from using cannabis that week.

Sham versus treatment At the beginning of the study, the researchers ruled out the 200-milligram condition as ineffective.

However, based on the study’s conclusion, daily CBD doses of 400 and 800 milligrams were found reduce participants’ cannabis intake. Specifically, these doses reduced urine THC levels by -94.21ng / mL and -72.02ng / mL, respectively.

People who took between 400 and 800 milligrams of CBD were also more likely to abstain longer than the placebo group: the 400 milligram CBD group abstained for a further half day per week. The 800 milligram dose group had 0.3 days per week of additional withdrawal. Both doses of CBD performed better on consumption and on withdrawal than placebo.

Throughout the study, participants did not experience any severe adverse events related to CBD use. suggesting that high-quality prescription CBD is relatively safe for use.

The future of CBD research – Studies have not determined exactly why CBD appears to help people quit using marijuana. Previous research indicates that CBD can reduce cannabis cravings and can reduce mental health symptoms like anxiety, which in turn influences use.

“CBD has contrasting and often opposite effects to THC in our endogenous cannabinoid systems,” says Freeman. “In this way, CBD is very different from a nicotine patch or other replacement therapies.”

THC, an active ingredient in marijuana that makes you “get high,” binds to specific brain receptors and influences reaction time, memory, and movement. CBD blocks the binding of brain receptors to cannabinoids and can make people feel more relaxed. In theory, this process could also explain why CBD can be useful, but more research is needed to be sure.

Freeman and his colleagues emphasize that these findings should not prompt people to run out of money and buy CBD to “self-medicate” if they are trying to cut down on cannabis use.

Over-the-counter CBD products contain low doses of CBD, about 25 milligrams, and have no guarantee of quality, Freeman explains. Commercially available CBD products also have a variety of dosages and sometimes contain THC. If you are looking for help, Freeman recommends that you speak to a healthcare professional first.

Summary:

Background: There is a substantial and unmet clinical need for pharmacological treatment of cannabis use disorders. Cannabidiol may offer a novel treatment, but it is unclear what doses may be effective or safe. Therefore, our goal was to identify effective doses and eliminate ineffective doses in a phase 2a trial using a Bayesian adaptive design.

Methods: We conducted a Phase 2a Bayesian, double-blind, placebo-controlled, randomized, adaptive trial at the Clinical Psychopharmacology Unit (University College London, London, UK). We used an adaptive Bayesian dose search design to identify effective or ineffective doses in the intermediate and final analysis stages a priori. Participants meeting the DSM-5 cannabis use disorder criteria were randomized (1: 1: 1: 1) in the first stage of the trial to a 4-week treatment with three different doses of oral cannabidiol (200 mg , 400 mg, or 800 mg) or matched placebo during an interruption attempt using a double-blind block randomisation sequence. All participants received a brief psychological intervention of motivational interviews. For the second stage of the trial, the new participants were randomized to placebo or doses considered effective in the interim analysis. The main objective was to identify the most effective dose of cannabidiol to reduce cannabis use. The primary endpoints were 11-nor-9-carboxy-à-9-tetrahydrocannabinol (THC-COOH): creatinine, increased days per week with cannabis withdrawal during treatment, or both, evidenced by the subsequent odds that Cannabidiol is better than placebo above 0.9. All analyzes were performed by intention to treat. This trial is registered with ClinicalTrials.gov (NCT02044809) and the EU Registry of Clinical Trials (2013-000361-36).

Recommendations: Between May 28, 2014 and August 12, 2015 (first stage), 48 participants were randomly assigned to placebo (n = 12) and cannabidiol 200 mg (n = 12), 400 mg (n = 12) and 800 mg (n = 12) In the interim analysis, cannabidiol 200 mg was removed from the trial as an ineffective dose. Between May 24, 2016 and January 12, 2017 (second stage), randomization continued and 34 additional participants (1: 1: 1) were assigned to cannabidiol 400 mg (n = 12), cannabidiol 800 mg (n = 11) and placebo (n = 11). In the final analysis, cannabidiol 400 mg and 800 mg exceeded the primary endpoint criteria (0.9) for both primary outcomes. For the urine THC-COOH: creatinine ratio, the probability of being the most effective dose compared to placebo given the observed data was 0.9995 for cannabidiol 400 mg and 0.965 for cannabidiol 800 mg. For days with cannabis withdrawal, the probability of being the most effective dose compared to placebo given the observed data was 0.9966 for cannabidiol 400 mg and 0.9924 for cannabidiol 800 mg. Compared to placebo, cannabidiol 400 mg decreased THC-COOH: creatinine ratio by –94 · 21 ng / mL (estimated 95% range –161 · 83 to –35 · 56) and increased cannabis withdrawal by 0 · 48 days per week (0 · 15 to 0 · 82). Compared to placebo, cannabidiol 800 mg decreased THC-COOH: creatinine ratio by –72 · 02 ng / ml (–135 · 47 to –19 · 52) and increased cannabis withdrawal by 0 · 27 days per week (–0 · 09 to 0 · 64). Cannabidiol was well tolerated, with no serious adverse events recorded, and 77 (94%) of 82 participants completed the treatment.

Interpretation: In the first randomized clinical trial of cannabidiol for cannabis use disorder, cannabidiol 400 mg and 800 mg were safe and more effective than placebo in reducing cannabis use.