title: Extended-Release Injectable Naltrexone (XR-NTX) With Intensive Psychosocial Therapy for Amphetamine-Dependent Persons Seeking Treatment: A Placebo-Controlled Trial.
abstract: Explore the efficacy of extended-release injectable naltrexone (XR-NTX) for preventing relapse to amphetamine use.
  
  
  
  Clinical trial of 100 amphetamine-dependent, treatment-seeking patients who were randomized to 6 monthly 380 mg doses of XR-NTX or matching placebo before entering intensive outpatient after varying lengths of inpatient treatment in Reykjavik, Iceland. Weekly urine drug tests, retention, and standardized instruments assessed efficacy.
  
  
  
  Of 169 approached, 100 were randomized. Although amphetamine dependence was the main reason for seeking treatment, three-quarters or more of participants had 1 or more other substance dependencies. Of 51 randomized to XR-NTX, 20 received 4 or more injections; of 49 assigned to placebo, 26 received 4 or more injections. Of the planned 2400 weekly urine drug tests, 1247 were collected (52%); 4% of these were positive for amphetamine, 8% for benzodiazepine, 7% for marijuana, 1% for cocaine, and 1% for opioid. XR-NTX had no effect on amphetamine-positive tests, retention, or other outcomes. Those providing half or more of their tests attended more weeks of treatment than those providing less than half of their tests (m = 10.76 vs 3.31; t (92) = 5.91, P < 0.0001), and 92 participants provided at least 1 test.
  
  
  
  Adding XR-NTX to the usual combination of inpatient and intensive outpatient treatment did not reduce amphetamine use. The low prevalence of substance use among collected urine samples, and the association between collected samples and weeks in treatment, was consistent with other studies showing that staying in treatment is associated with better outcomes.
authors.affiliation: Society of Alcoholism and Other Addictions, Vogur Hospital, Reykjavík, Iceland (VR, IH, TT, ME); Department of Psychiatry, Perelman School of Medicine at the University of Pennsylvania, Treatment Research Institute, Philadelphia, PA (GEW); and the National Institute on Drug Abuse, Rockville, MD (JK).
authors.forename: Valgerdur
authors.initials: V
authors.lastname: Runarsdottir
authors.forename: Ingunn
authors.initials: I
authors.lastname: Hansdottir
authors.forename: Thorarinn
authors.initials: T
authors.lastname: Tyrfingsson
authors.forename: Magnus
authors.initials: M
authors.lastname: Einarsson
authors.forename: Karen
authors.initials: K
authors.lastname: Dugosh
authors.forename: Charlotte
authors.initials: C
authors.lastname: Royer-Malvestuto
authors.forename: Helen
authors.initials: H
authors.lastname: Pettinati
authors.forename: Jag
authors.initials: J
authors.lastname: Khalsa
authors.forename: George E
authors.initials: GE
authors.lastname: Woody
mesh_terms: D000328:Adult; D000553:Ambulatory Care / Q000379:methods; D019969:Amphetamine-Related Disorders / Q000175:diagnosis / Q000517:prevention & control* / Q000534:rehabilitation; D003131:Combined Modality Therapy; D003692:Delayed-Action Preparations; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006760:Hospitalization; D006801:Humans; D007273:Injections, Intramuscular; D008297:Male; D015233:Models, Statistical; D009271:Naltrexone / Q000008:administration & dosage* / Q000627:therapeutic use; D009292:Narcotic Antagonists / Q000008:administration & dosage* / Q000627:therapeutic use; D011613:Psychotherapy; D012008:Recurrence; D055502:Secondary Prevention / Q000379:methods*; D016320:Substance Abuse Treatment Centers; D016896:Treatment Outcome
chemical_list: D003692:Delayed-Action Preparations; D009292:Narcotic Antagonists; D009271:Naltrexone