Atomoxetine does not alter cocaine use in cocaine dependent individuals: A double blind randomized trial

Sharon L. Walsh, Lisa S. Middleton, Conrad J. Wong, Paul A. Nuzzo, Charles L. Campbell, Craig R. Rush, Michelle R. Lofwall

Research output: Contribution to journalArticlepeer-review

26 Scopus citations


Background: Cocaine abuse continues to be a significant public health problem associated with morbidity and mortality. To date, no pharmacotherapeutic approach has proven effective for treating cocaine use disorders. Preclinical and clinical evidence suggests that noradrenergic activity may play a role in mediating some effects of cocaine and may be a rational target for treatment. Methods: This double blind, placebo-controlled randomized, parallel group, 12-week outpatient clinical trial enrolled cocaine dependent individuals seeking treatment to examine the potential efficacy of the selective norepinephrine reuptake inhibitor, atomoxetine (80. mg/day; p.o.; n=25), compared to placebo (n=25). Subjects were initially stratified on cocaine use (<15 days or ≥15 days of the last 30), age and race using urn randomization. Attendance, medication adherence and study compliance were reinforced with contingency management, and weekly counseling was offered. An array of measures (vital signs, laboratory chemistries, cognitive and psychomotor tests, cocaine craving and urine samples for drug testing) was collected throughout the study and at follow-up. Results: Survival analysis revealed no differences in study retention between the two groups, with approximately 56% of subjects completing the 12-week study (Cox analysis χ2=.72; p=.40; Hazard Ratio 1.48 [95% CI 0.62-3.39]). GEE analysis of the proportion of urine samples positive for benzoylecgonine, a cocaine metabolite, revealed no differences between the atomoxetine and placebo groups (χ2=0.2, p=.66; OR=0.89 [95% CI 0.41-1.74]). Atomoxetine was generally well tolerated in this population. Conclusions: These data provide no support for the utility of atomoxetine in the treatment of cocaine dependence.

Original languageEnglish
Pages (from-to)150-157
Number of pages8
JournalDrug and Alcohol Dependence
Issue number1-3
StatePublished - Jun 1 2013

Bibliographical note

Funding Information:
This project was supported by a grant from the National Institute on Drug Abuse (NIDA) R01 DA022191 (SLW). We are grateful to Eli Lilly & Co., Indianapolis, Indiana for their gratis provision of study medication (atomoxetine and matched-placebos). Neither NIDA nor Eli Lilly & Co. had any role in the study design, collection, analysis and interpretation of the data or in the decision to submit the paper. The initial draft was shared with staff from Eli Lilly & Co. for their review, and no changes resulted from this process.


  • Atomoxetine
  • Clinical trial
  • Cocaine
  • Dependence
  • Norepinephrine
  • Treatment

ASJC Scopus subject areas

  • Toxicology
  • Pharmacology
  • Psychiatry and Mental health
  • Pharmacology (medical)


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