Sustained-release dexamfetamine in the treatment of chronic cocaine-dependent patients on heroin-assisted treatment: a randomised, double-blind, placebo-controlled trial
Abstract
Background Heroin-assisted treatment is effective for methadone treatment-refractory heroin-dependent patients, but continued comorbid cocaine dependence remains problematic. Sustained-release dexamfetamine is a promising agonist pharmacotherapy for cocaine dependence and we aimed to assess its acceptance, efficacy, and safety. Methods In this multicentre, randomised, double-blind, placebo-controlled trial, patients who were treatment-refractory, as indicated by at least two earlier failed treatments aimed at reducing or abstaining from cocaine use, and who regularly (≥8 days/month) used crack-cocaine were enrolled from four heroin-assisted treatment centres in the Netherlands. Eligible patients were randomly assigned (1:1) to receive either 12 weeks of daily, supervised prescription of 60 mg/day oral sustained-release dexamfetamine or placebo in addition to co-prescribed methadone and diacetylmorphine. Randomisation was done by the collaborating pharmacist, using a computer-generated random number sequence with stratification by treatment centre in blocks of four per stratum. Randomisation was masked to patients, staff, and researchers throughout the study. The primary outcome was the number of self-reported days of cocaine use during study treatment, assessed every 4 weeks. Primary and safety analyses were done in the intention-to-treat population. The study was registered with the European Union Drug Regulating Authorities Clinical Trials (EUdraCT 2013-004024-11) and with…
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From The ASAM/AAAP Clinical Practice Guideline on the Management of Stimulant Use Disorder (2024) · cites this paper as [235]
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- Authors
- Nuijten, M., Blanken, P., van de Wetering, B., Nuijen, B., van den Brink, W., & Hendriks, V. M.
- Affiliations
- Parnassia Groep (NL)
- The Netherlands Cancer Institute (NL)
- Leiden University (NL)
- Corresponding author
- Nuijten, Mascha
- Venue
- The Lancet
- Publisher
- Elsevier BV
- Published
- 2016-05
- Volume
- 387
- Issue
- 10034
- Pages
- 2226-2234
- ISSN
- 0099-5355 (ISSN-L)
- 0140-6736
- OpenAlex
- W2305718570
- Cited by
- 87
- References
- 32
- Citations by year
- 2026: 2 · 2025: 7 · 2024: 6 · 2023: 6 · 2022: 10 · 2021: 13 · 2020: 12 · 2019: 8 · 2018: 8 · 2017: 7 · 2016: 8
- FWCI
- 10.28
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- The Lancet (publishedVersion)
- PubMed (publishedVersion)
- Data Archiving and Networked Services (DANS) (submittedVersion)
- Pure Amsterdam UMC (submittedVersion)
- Funders
- H. Lundbeck A/S
- Topics
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Opioid Use Disorder Treatment
- Health Sciences › Medicine › Epidemiology › Substance Abuse Treatment and Outcomes
- Health Sciences › Medicine › Epidemiology › HIV, Drug Use, Sexual Risk
- Keywords
- d-amphetamine, sustained-release formulation, cocaine dependence, heroin-assisted treatment, methadone, heroin, dual diagnosis, adverse events, opioid substitution therapy, crack cocaine, substance use comorbidity, harm reduction
- MeSH terms
- Administration, Oral, Central Nervous System Stimulants, Chronic Disease, Delayed-Action Preparations, Dextroamphetamine, Double-Blind Method, Female, Heroin Dependence, Humans, Male, Middle Aged, Patient Acceptance of Health Care, Crack Cocaine, Treatment Outcome, Cocaine-Related Disorders
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