title: Pilot study of the effects of lisdexamfetamine on cocaine use: A randomized, double-blind, placebo-controlled trial.
abstract: BACKGROUND
  Amphetamine analogs have been demonstrated to have some efficacy in reducing use in cocaine dependent individuals. However, these agents also have potential for abuse. Lisdexamfetamine (LDX), a lysine+dextroamphetamine formulation, has been approved for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) and as a prodrug, has less abuse potential.
  
  
  OBJECTIVE
  This pilot study sought to evaluate the safety, tolerability, and efficacy of LDX as a candidate treatment for cocaine dependence.
  
  
  METHODS
  A randomized, double-blind, placebo-controlled parallel group study served to evaluate LDX in 43 cocaine-dependent individuals: (1) placebo (PBO; 0mg, n=21), (2) LDX (70mg, n=22). Participants received medication for 14 weeks. Cocaine use was determined based on urine analysis for benzoylecgonine (BE; a cocaine metabolite).
  
  
  RESULTS
  Retention rates were higher though not significantly different in the PBO (71.4%) than the LDX condition (57.1%). Compared to those in the PBO condition, those receiving LDX were more likely to report experiencing (ps<0.05) diarrhea (45.5% vs. 14.3%), headaches (45.5% vs. 9.5%), and anxiety (31.8% vs. 4.8%). No differences in medication conditions were observed for blood pressure, heart rate, or body weight. In the randomized sample, no differences in cocaine use were seen. Those receiving LDX reported significantly less craving for cocaine than participants receiving PBO.
  
  
  CONCLUSIONS
  LDX did not significantly reduce cocaine use compared to PBO in the randomized sample.
authors.affiliation: Department of Psychiatry, University of Minnesota, Minneapolis, United States. Electronic address: moon0078@umn.edu.
authors.forename: Marc E
authors.initials: ME
authors.lastname: Mooney
authors.affiliation: Department of Psychiatry, University of Minnesota, Minneapolis, United States.
authors.forename: David V
authors.initials: DV
authors.lastname: Herin
authors.affiliation: Department of Psychiatry, University of Minnesota, Minneapolis, United States.
authors.forename: Sheila
authors.initials: S
authors.lastname: Specker
authors.affiliation: Department of Psychiatry, University of Minnesota, Minneapolis, United States.
authors.forename: David
authors.initials: D
authors.lastname: Babb
authors.affiliation: New York State Psychiatric Institute & Department of Psychiatry, Columbia University, United States.
authors.forename: Frances R
authors.initials: FR
authors.lastname: Levin
authors.affiliation: Department of Psychiatry, University of Minnesota, Minneapolis, United States.
authors.forename: John
authors.initials: J
authors.lastname: Grabowski
mesh_terms: D000328:Adult; D000697:Central Nervous System Stimulants / Q000627:therapeutic use*; D019970:Cocaine-Related Disorders / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D000069478:Lisdexamfetamine Dimesylate / Q000627:therapeutic use*; D008297:Male; D010865:Pilot Projects; D011355:Prodrugs / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D000697:Central Nervous System Stimulants; D011355:Prodrugs; D000069478:Lisdexamfetamine Dimesylate
keywords: Agonist-like treatment; Amphetamine analogs; Cocaine; Dextroamphetamine; Lisdexamfetamine dimesylate; l-Lysine-dextroamphetamine