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NCT00603434
Double-Blind, Placebo-Controlled Assessment of Potential Interactions Between Intravenous Methamphetamine and Osmotic-Release Methylphenidate (OROS-MPH)
Phase 1 trial testing OROS-MPH in Methamphetamine Dependence in 16 participants. Completed in 1 March 2009.
1 March 2009
Quick facts
| Lead sponsor | University of Cincinnati |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | diagnostic |
| Enrollment | 16 |
| Start date | 1 January 2008 |
| Primary completion | 1 March 2009 |
| Estimated completion | 1 March 2009 |
| Sites | 2 locations across United States, Canada |
Drugs / interventions tested
- OROS-MPH
- OROS-MPH
- OROS-MPH
Conditions studied
- Methamphetamine Dependence — all drugs for Methamphetamine Dependence →
- Methamphetamine Abuse — all drugs for Methamphetamine Abuse →
Sponsor
University of Cincinnati
Who can join
Adults 18 to 45, any sex, with Methamphetamine Dependence or Methamphetamine Abuse. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Safety of the OROS-MPH concurrent with d-methamphetamine infusions.
Time frame: Daily
Sponsor's own description
This is a human inpatient clinical pharmacology study to assess potential interactions between intravenous (i.v.) methamphetamine infusion and oral osmotic release methylphenidate (OROS-MPH). The primary objective of this study is to determine the safety of the OROS-MPH concurrent with i.v. d-methamphetamine infusions of 15 mg and 30 mg. Safety outcome measures include cardiovascular responses \[heart rate (HR), blood pressure (BP), and electrocardiograph (ECG) measurements\], oral temperature, adverse events (AEs), and clinical laboratory analyses.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT00603434
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00603434 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Cincinnati
- Last refreshed: 11 January 2017
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00603434.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing