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NCT00829777: AIKO-150
A Phase-I, Two-Stage, Double-Blind, Placebo-Controlled, Pharmacokinetic and Pharmacodynamic Trial of Low Doses of Intravenous 6β-Naltrexol (AIKO-150) in Opioid-Dependent Subjects.
Phase 1 trial testing 6β-Naltrexol escalating doses from 0.05-0.5 mg IV in Opiate Addiction in 8 participants. Completed in 1 September 2009.
1 September 2009
Quick facts
| Lead sponsor | California Pacific Medical Center Research Institute |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | single group |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 8 |
| Start date | 1 March 2009 |
| Primary completion | 1 September 2009 |
| Estimated completion | 1 September 2009 |
| Sites | 1 location across United States |
Drugs / interventions tested
- 6β-Naltrexol escalating doses from 0.05-0.5 mg IV — full drug profile →
Conditions studied
- Opiate Addiction — all drugs for Opiate Addiction →
Sponsor
California Pacific Medical Center Research Institute
Who can join
Adults 21 to 45, any sex, with Opiate Addiction. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
- 6β-Naltrexol will have 13 hr half-life. Plasma collected
Time frame: -0-24 hrs post dose -
- 6β-Naltrexol pharmacokinetic profile in opioid-dependent population will be similar in non-opioid-dependent population. Plasma levels collected
Time frame: 0-8 hrs post dose
Sponsor's own description
The purpose of this study is to evaluate the safety and efficacy of intravenous 6β-Naltrexol administered to opiate dependent subjects
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 NCT00829777
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other California Pacific Medical Center Research Institute trials
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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 NCT00829777 (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 California Pacific Medical Center Research Institute
- Last refreshed: 14 September 2009
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/NCT00829777.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing