Safety Study of Intravenous 6β-Naltrexol (AIKO-150) in Opioid-Dependent Subjects

This study has been completed.
Sponsor:
Information provided by:
California Pacific Medical Center Research Institute
ClinicalTrials.gov Identifier:
NCT00829777
First received: January 23, 2009
Last updated: September 14, 2009
Last verified: September 2009

January 23, 2009
September 14, 2009
March 2009
September 2009   (final data collection date for primary outcome measure)
  • - 6β-Naltrexol will have 13 hr half-life. Plasma collected [ Time Frame: -0-24 hrs post dose ] [ Designated as safety issue: No ]
  • - 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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00829777 on ClinicalTrials.gov Archive Site
  • -6β-Naltrexol will have a lower potency in precipitating withdrawal and be better tolerated than Naloxone assessed by vital signs, objective/subjective ate Withdrawal Scales, Visual Analog Scales, Pupil Size and GI Motility measures [ Time Frame: 0-8 hrs post dose ] [ Designated as safety issue: No ]
  • 6β-Naltrexol dose-dependent increases to reverse methadone-induced bowel dysfunction. Plasma levels and Hydrogen Breath Tests [ Time Frame: 0-8 hrs post dose ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Safety Study of Intravenous 6β-Naltrexol (AIKO-150) in Opioid-Dependent Subjects
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.

The purpose of this study is to evaluate the safety and efficacy of intravenous 6β-Naltrexol administered to opiate dependent subjects

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Opiate Addiction
Drug: 6β-Naltrexol escalating doses from 0.05-0.5 mg IV

Drug: Naloxone 0.1 mg IV/5 minutes to all subjects to determine tolerability to precipitated withdrawal during screening. Those that tolerate withdrawal proceed to Stage 1:

Drug: Lactulose 10 gm orally plus 3 IV infusions 30 minutes apart of Naloxone 0.1 mg IV and 2 placebo given randomly to all subjects. If tolerated, proceed to 5 additional medication dosing sessions with all subjects receiving oral Lactulose 10 GM plus IV escalating 6β-Naltrexol 0.05 mg, 0.15 mg, 0.5 mg with a randomized placebo.

Other Names:
  • Naloxone
  • 6β-Naltrexol
  • Lactulose
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
8
September 2009
September 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Opiate dependent males and females age 21-45 on stable doses of methadone
  • Fluent English speaker
  • Willing and able to give written consent

Exclusion Criteria:

  • Pregnancy or lactation

FOR MORE DETAILS CONTACT THE RESEARCH CLINIC.

Both
21 Years to 45 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00829777
28.073-2, PR#0830A, IRB# 26.073-2
No
John Mendelson, M.D., Principal Investigator, Addiction & Pharmacology Research Laboratory, California Pacific Medical Center Research Institute
California Pacific Medical Center Research Institute
Not Provided
Principal Investigator: John E Mendelson, MD California Pacific Medical Center Research Institute
California Pacific Medical Center Research Institute
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP