Trial reportBMJ open2021
Safety and tolerability of oral lisdexamfetamine in adults with methamphetamine dependence: a phase-2 dose-escalation study.
Trial report in BMJ open, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
12 citing papers in PubMed, 24 citations in OpenAlex.
- Lisdexamfetamine in the treatment of methamphetamine dependence: A randomised, placebo-controlled trial.Addiction (Abingdon, England) · 2025Trial
- Article
- Article
- Commentary on Ezard et al.: Agonist-based medications for stimulant use disorder-Distinguishing their true colours.Addiction (Abingdon, England) · 2025Article
- Emerging medications and pharmacological treatment approaches for substance use disorders.Pharmacology, biochemistry, and behavior · 2025Review
- Protocol of an open-label safety and feasibility pilot study of ketamine-assisted psychotheraBMJ open · 2025Article
- The Therapeutic Potential of Amphetamine-like Psychostimulants.Life (Basel, Switzerland) · 2023Review
- Clinical management of psychostimulant withdrawal: review of the evidence.Addiction (Abingdon, England) · 2023Review
- Prescription psychostimulants for cocaine use disorder: A review from molecular basis to clinical approach.Addiction biology · 2023Review
- The Use of Lisdexamfetamine to Treat ADHD in a Patient with Stimulant (Methamphetamine) Use Disorder.Case reports in psychiatry · 2023Article
- Continuing Increase in Stimulant Dependence - Time to Implement Medical Treatment.Canadian journal of psychiatry. Revue canadienne de psychiatrie · 2022Article
- Trial protocol of an open label pilot study of lisdexamfetamine for the treatment of acute methamphetamine withdrawal.PloS one · 2022Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors at 5 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesTo examine the safety of an agonist-type treatment, lisdexamfetamine (LDX), at 250 mg/day among adults with methamphetamine (MA) dependence.
designA dose-escalating, phase-2, open-label, single-group study of oral LDX at two Australian drug treatment services.
settingThe study was conducted at two Australian stimulant use disorder treatment clinics.
participantsThere were 16 participants: at least 18 years old, MA dependent for at least the preceding 2 years using ICD-10 criteria, reporting use of MA on at least 14 of the preceding 28 days.
interventionsDaily, supervised LDX of 100-250 mg, single-blinded to dose, ascending-descending regimen over 8 weeks (100-250 mg over 4 weeks; followed by 4-week dose reduction regimen, 250-100 mg). Participants were followed through to week 12. OUTCOMES: Primary outcomes were safety, drug tolerability and regimen completion at the end of week 4. Participants were followed to week 12. Secondary outcomes included: change in MA use; craving; withdrawal; severity of dependence; risk behaviour; change in other substance use; medication acceptability; potential for non-prescription use; adherence and neurocognitive functioning.
resultsFourteen of 16 participants (87.5%) completed escalation to 250 mg/day. Two participants withdrew from the trial in the first week: one relocated away from the study site, the other self-withdrew due to a possible, known side effect of LDX (agitation). There was one serious adverse event of suicidal ideation which resolved. All other adverse events were mild or moderate in severity and known side effects of LDX. No participant was withdrawn due to adverse events. MA use decreased from a median of 21 days (IQR: 16-23) to 13 days (IQR: 11-17) over the 4-week escalation period (p=0.013).
conclusionsLDX at a dose of up to 250 mg/day was safe and well tolerated by study participants, warranting larger trials as a pharmacotherapy for MA dependence. TRIAL REGISTRATION NUMBER: ACTRN12615000391572.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.