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Generalizability of clinical trials for cannabis dependence to community samples.

ABSTRACT: There is growing concern that results of tightly controlled clinical trials may not generalize to broader community samples. To assess the proportion of community dwelling adults with cannabis dependence who would have been eligible for a typical cannabis dependence treatment study, we applied a standard set of eligibility criteria commonly used in cannabis outcome studies to a large (N=43,093) representative US adult sample interviewed face-to-face, the National Epidemiologic Survey on Alcohol and Related Conditions (NESARC). Approximately 80% of the community sample of adults with a diagnosis of cannabis dependence (N=133) would be excluded from participating in clinical trials by one or more of the common eligibility criteria. Individual study criteria excluded from 0% to 41.0% of the community sample. Legal problems, other illicit drug use disorders, and current use of fewer than 5 joints/week excluded the largest percentage of individuals. These results extend to cannabis dependence concerns that typical clinical trials likely exclude most community dwelling adults with the disorder. The results also support the notion that clinical trials tend to recruit highly selective samples, rather than adults who are representative of typical patients. Clinical trials should carefully evaluate the effects of eligibility criteria on the generalizability of their results. Even in efficacy trials, stringent exclusionary criteria could limit the representativeness of study results.

SUBMITTER: Okuda M

PROVIDER: S-EPMC3227418 | biostudies-literature | 2010 Sep

REPOSITORIES: biostudies-literature

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Generalizability of clinical trials for cannabis dependence to community samples.

Okuda Mayumi M Hasin Deborah S DS Olfson Mark M Khan Sharaf S SS Nunes Edward V EV Montoya Ivan I Liu Shang-Min SM Grant Bridget F BF Blanco Carlos C

Drug and alcohol dependence 20100526 1-2

There is growing concern that results of tightly controlled clinical trials may not generalize to broader community samples. To assess the proportion of community dwelling adults with cannabis dependence who would have been eligible for a typical cannabis dependence treatment study, we applied a standard set of eligibility criteria commonly used in cannabis outcome studies to a large (N=43,093) representative US adult sample interviewed face-to-face, the National Epidemiologic Survey on Alcohol ...[more]

PMID: 20537813

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Project description:ImportanceThere are no effective medications for treating dependence on cannabis.ObjectiveTo examine the safety and efficacy of nabiximols in the treatment of patients with cannabis dependence.Design, setting, and participantsThis parallel double-blind randomized clinical trial comparing nabiximols with placebo in a 12-week, multisite outpatient study recruited participants from February 3, 2016, to June 14, 2017, at 4 outpatient specialist alcohol and drug treatment services in New South Wales, Australia. Participants had cannabis dependence (as defined by the International Statistical Classification of Diseases and Related Health Problems, Tenth Revision) and were seeking treatment, were nonresponsive to prior treatment attempts, were 18 to 64 years of age, had no other substance use disorder, had no severe medical or psychiatric conditions, were not pregnant, were not mandated by a court to undergo treatment, and provided informed consent. Results for primary efficacy measures and all secondary outcomes were obtained using a modified intention-to-treat data set.InterventionsParticipants received 12-week treatment involving weekly clinical reviews, structured counseling, and flexible medication doses-up to 32 sprays daily (tetrahydrocannabinol, 86.4 mg, and cannabidiol, 80 mg), dispensed weekly.Main outcomes and measuresPrimary outcome was self-reported number of days using illicit cannabis during the 12-week period. Other outcomes included alternate cannabis use parameters (periods of abstinence, withdrawal, cravings, and problems), safety parameters (adverse events and aberrant medication use), health status, other substance use, and treatment retention.ResultsA total of 128 participants (30 women and 98 men; mean [SD] age, 35.0 [10.9] years) were randomized and received at least 1 dose of study medication. Participants had used a mean (SD) of 2.3 (2.1) g of cannabis on a mean (SD) of 25.7 (4.5) days in the past 28 days. Treatment retention was comparable for the 2 groups (placebo, 30 of 67 participants [44.8%]; nabiximols, 30 of 61 participants [49.2%]), and both groups used similar mean (SD) doses (placebo, 18.5 [9.5] sprays daily; nabiximols, 17.6 [9.5] sprays daily, equivalent to a mean [SD] of 47.5 [25.7] mg of tetrahydrocannabinol and 44.0 [23.8] mg of cannabidiol). For the primary end point, the placebo group reported significantly more days using cannabis during the 12 weeks (mean [SD], 53.1 [33.0] days) than the nabiximols group (mean [SD], 35.0 [32.4] days; estimated difference, 18.6 days; 95% CI, 3.5-33.7 days; P = .02). Both groups showed comparable improvements in health status, with no substantial changes in other substance use. Medication was well tolerated with few adverse events.Conclusions and relevanceThis study demonstrates that cannabinoid agonist treatment, in this case using nabiximols, in combination with psychosocial interventions is a safe approach for reducing cannabis use among individuals with cannabis dependence who are seeking treatment.Trial registrationanzctr.org.au Identifier: ACTRN12616000103460.

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Generalizability of clinical trials for cannabis dependence to community samples.

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Generalizability of clinical trials for cannabis dependence to community samples.

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