PMID- 29420073 OWN - NLM STAT- MEDLINE DCOM- 20190926 LR - 20200306 IS - 1097-9891 (Electronic) IS - 0095-2990 (Print) IS - 0095-2990 (Linking) VI - 44 IP - 6 DP - 2018 TI - Open-label pilot study of injectable naltrexone for cannabis dependence. PG - 619-627 LID - 10.1080/00952990.2017.1423321 [doi] AB - 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. FAU - Notzon, Daniel P AU - Notzon DP AD - a Division on Substance Abuse , New York State Psychiatric Institute , New York , NY , USA. AD - b Department of Psychiatry , College of Physicians and Surgeons, Columbia University , New York , NY , USA. FAU - Kelly, Meredith A AU - Kelly MA AD - a Division on Substance Abuse , New York State Psychiatric Institute , New York , NY , USA. AD - b Department of Psychiatry , College of Physicians and Surgeons, Columbia University , New York , NY , USA. FAU - Choi, C Jean AU - Choi CJ AD - c Division of Biostatistics , New York State Psychiatric Institute , New York , NY , USA. FAU - Pavlicova, Martina AU - Pavlicova M AD - d Department of Biostatistics , Mailman School of Public Health, Columbia University , New York , NY , USA. FAU - Mahony, Amy L AU - Mahony AL AD - a Division on Substance Abuse , New York State Psychiatric Institute , New York , NY , USA. FAU - Brooks, Daniel J AU - Brooks DJ AD - a Division on Substance Abuse , New York State Psychiatric Institute , New York , NY , USA. FAU - Mariani, John J AU - Mariani JJ AD - a Division on Substance Abuse , New York State Psychiatric Institute , New York , NY , USA. AD - b Department of Psychiatry , College of Physicians and Surgeons, Columbia University , New York , NY , USA. FAU - Levin, Frances R AU - Levin FR AD - a Division on Substance Abuse , New York State Psychiatric Institute , New York , NY , USA. AD - b Department of Psychiatry , College of Physicians and Surgeons, Columbia University , New York , NY , USA. LA - eng GR - K24 DA029647/DA/NIDA NIH HHS/United States GR - T32 DA007294/DA/NIDA NIH HHS/United States PT - Journal Article PT - Research Support, N.I.H., Extramural DEP - 20180208 PL - England TA - Am J Drug Alcohol Abuse JT - The American journal of drug and alcohol abuse JID - 7502510 RN - 0 (Narcotic Antagonists) RN - 5S6W795CQM (Naltrexone) SB - IM MH - Adult MH - Female MH - Humans MH - Injections, Intramuscular MH - Male MH - Marijuana Abuse/*drug therapy MH - Middle Aged MH - Naltrexone/administration & dosage/*therapeutic use MH - Narcotic Antagonists/administration & dosage/*therapeutic use MH - Pilot Projects MH - Treatment Outcome PMC - PMC6082728 MID - NIHMS947015 OTO - NOTNLM OT - Cannabis OT - marijuana OT - medication OT - pilot OT - treatment COIS- 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. EDAT- 2018/02/09 06:00 MHDA- 2019/09/27 06:00 PMCR- 2018/09/06 CRDT- 2018/02/09 06:00 PHST- 2018/02/09 06:00 [pubmed] PHST- 2019/09/27 06:00 [medline] PHST- 2018/02/09 06:00 [entrez] PHST- 2018/09/06 00:00 [pmc-release] AID - 10.1080/00952990.2017.1423321 [doi] PST - ppublish SO - Am J Drug Alcohol Abuse. 2018;44(6):619-627. doi: 10.1080/00952990.2017.1423321. Epub 2018 Feb 8.