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. 2018;44(6):619-627.
doi: 10.1080/00952990.2017.1423321. Epub 2018 Feb 8.

Open-label pilot study of injectable naltrexone for cannabis dependence

Daniel P Notzon  1   2 , Meredith A Kelly  1   2 , C Jean Choi  3 , Martina Pavlicova  4 , Amy L Mahony  1 , Daniel J Brooks  1 , John J Mariani  1   2 , Frances R Levin  1   2
Affiliations

Open-label pilot study of injectable naltrexone for cannabis dependence

Daniel P Notzon et al. Am J Drug Alcohol Abuse. 2018.

Abstract

Background: There are no FDA-approved pharmacotherapies for cannabis use disorders (CUD), despite the evaluation of numerous medications. Notably, chronic dosing of oral naltrexone decreases self-administration of cannabis in human laboratory studies.

Objectives: To test the feasibility of long-acting injectable naltrexone for the treatment of CUD, while obtaining preliminary safety and efficacy data.

Methods: Twelve adult participants (seven male) meeting DSM-IV-TR criteria for cannabis dependence enrolled into an 8-week, open-label pilot study conducted at an academic treatment research clinic. They received 380 mg intramuscular injections of long-acting naltrexone on study day 1 and at the start of study week 5. Outcome measures included percentages of study completers and participants who received the second injection, frequency of adverse events (AEs), and cannabis consumption measured by average daily grams, dollars, and using days per week as measured by timeline follow-back and urine oral delta-9-tetrahydrocannabinol (THC) concentrations.

Results: Of the 12 participants enrolled in the study, 9 completed the study and 6 received the second injection. There were no severe AEs but an unexpected AE led to the addition of supportive medications to the protocol. Number of cannabis use days per week significantly decreased over the course of the study (p = .001). Creatinine-corrected urine THC concentrations and average daily cannabis use per study week in grams and in dollars did not decrease over the course of the study.

Conclusions: Long-acting injectable naltrexone is a feasible intervention for CUD worthy of further study in a placebo-controlled, double-blinded randomized clinical trial.

Keywords: Cannabis; marijuana; medication; pilot; treatment.

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Conflict of interest statement

Declaration of Interest

Dr. Notzon, Dr. Kelly, Ms. Choi, Dr. Pavlicova, Dr. Mariani, Amy Mahony and Daniel Brooks have no disclosures. Dr. Levin served as a consultant to GW Pharmaceuticals and to Eli Lilly, and served on an advisory board to Shire in 2005–2007.

Figures

Figure 1
Figure 1
Cannabis use days per week.
See this image and copyright information in PMC

References

    1. Quality CfBHSa. 2015 National Survey on Drug Use and Health: detailed Tables. Rockville, MD: Substance Abuse and Mental Health Services Administration; 2016.
    1. Budney AJ, Roffman R, Stephens RS, Walker D. Marijuana dependence and its treatment. Addict Sci Clin Pract. 2007;4(1):4–16. doi: 10.1151/ASCP07414. - DOI - PMC - PubMed
    1. Kathmann M, Flau K, Redmer A, Trankle C, Schlicker E. Cannabidiol is an allosteric modulator at mu- and delta-opioid receptors. Naunyn-Schmiedeberg’s Archiv Pharmacol. 2006;372(5):354–61. doi: 10.1007/s00210-006-0033-x. - DOI - PubMed
    1. Manzanares J, Corchero J, Romero J, Fernandez-Ruiz JJ, Ramos JA, Fuentes JA. Pharmacological and biochemical interactions between opioids and cannabinoids. Trends Pharmacol Sci. 1999;20(7):287–94. doi: 10.1016/S0165-6147(99)01339-5. - DOI - PubMed
    1. Cooper ZD, Haney M. Opioid antagonism enhances marijuana’s effects in heavy marijuana smokers. Psychopharmacol. 2010;211(2):141–48. doi: 10.1007/s00213-010-1875-y. - DOI - PMC - PubMed

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