A Phase 2 interventional study of Levoacetyl Methadol and Levoacetyl Methadol in Heroin Dependence and Opioid-Related Disorders, sponsored by National Institute on Drug Abuse (NIDA). Completed at 1 site in United States. Open to participants aged 25 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-01-12.
Sponsored by National Institute on Drug Abuse (NIDA) · Phase 2, Interventional, and Treatment
Heroin dependence remains a major addiction problem in the United States. The purpose of this study is to determine the effectiveness of levoacetyl methadol (ORLAAM) in treating heroin dependent individuals.
Heroin is a highly addictive drug, and its abuse has both medical and social consequences. ORLAAM is approved to treat both opiate and narcotic dependence. The purpose of this study is to determine the efficacy of ORLAAM in treating heroin dependent individuals. In addition, this study will determine the most effective dosing regimen of ORLAAM.
This study will last 20 weeks. Participants will be randomly assigned to receive one of three dosing conditions: 1) standard fixed dose, 2) dose-by-weight, and 3) dose effect. The dose effect condition will include a dose of ORLAAM dependent on opiate use and withdrawal symptoms associated with opiate use; doses may be adjusted throughout the study. All participants will receive cognitive behavioral therapy throughout the study.
90 studies on the registry are indexed under Heroin Dependence; 1 is open to participants now.
This study's enrollment of 142 is above the median of 87 across 57 interventional studies indexed under Heroin Dependence.
Browse Heroin Dependence studies →National Institute on Drug Abuse (NIDA) is the lead sponsor of 393 studies on the registry; 19 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 6 (43%) have results posted.
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The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LAAM WtDosing up to 1.0 mg/kg Stable 1.0 mg/kg/day for 20 weeks
Drug: Levoacetyl Methadol
LAAM MaxEffect to 48 mg Adjust to effect (+/-)
Drug: Levoacetyl Methadol
LAAM Fixed Dose up to 48 mg 48 mg
Drug: Levoacetyl Methadol
WtDosing up to 1.0 mg/kg Stable 1.0 mg/kg/day
Also known as: LAAM
MaxEffect+CBT evaluation to 48 mg Adjust to effect (+/-)
Also known as: LAAM
LAAM Fixed Dose evaluation up to 48 mg 48 mg
Also known as: LAAM
drug use
Time frame: herion use over 20 week period
This study is completed, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Methadyl Acetate
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