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

This study has been completed.
Information provided by:
California Pacific Medical Center Research Institute Identifier:
First received: January 23, 2009
Last updated: September 14, 2009
Last verified: September 2009
The purpose of this study is to evaluate the safety and efficacy of intravenous 6β-Naltrexol administered to opiate dependent subjects

Condition Intervention Phase
Opiate Addiction
Drug: 6β-Naltrexol escalating doses from 0.05-0.5 mg IV
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:

Further study details as provided by California Pacific Medical Center Research Institute:

Primary Outcome Measures:
  • - 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 ]

Secondary Outcome Measures:
  • -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 ]
  • 6β-Naltrexol dose-dependent increases to reverse methadone-induced bowel dysfunction. Plasma levels and Hydrogen Breath Tests [ Time Frame: 0-8 hrs post dose ]

Estimated Enrollment: 8
Study Start Date: March 2009
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    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

Ages Eligible for Study:   21 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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


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Please refer to this study by its identifier: NCT00829777

United States, California
CPMC Addiction & Pharmacology Research Laboratory (APRL)
San Francisco, California, United States, 94110
Sponsors and Collaborators
California Pacific Medical Center Research Institute
Principal Investigator: John E Mendelson, MD California Pacific Medical Center Research Institute
  More Information

Responsible Party: John Mendelson, M.D., Principal Investigator, Addiction & Pharmacology Research Laboratory, California Pacific Medical Center Research Institute Identifier: NCT00829777     History of Changes
Other Study ID Numbers: 28.073-2
IRB# 26.073-2
Study First Received: January 23, 2009
Last Updated: September 14, 2009

Keywords provided by California Pacific Medical Center Research Institute:
peripheral effects of withdrawal
central effects of withdrawal

Additional relevant MeSH terms:
Opioid-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists
Gastrointestinal Agents processed this record on May 23, 2017