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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00829777
First Posted: January 27, 2009
Last Update Posted: September 16, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
California Pacific Medical Center Research Institute
  Purpose
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 (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.

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
  Eligibility

Information from the National Library of Medicine

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

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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00829777


Locations
United States, California
CPMC Addiction & Pharmacology Research Laboratory (APRL)
San Francisco, California, United States, 94110
Sponsors and Collaborators
California Pacific Medical Center Research Institute
Investigators
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
ClinicalTrials.gov Identifier: NCT00829777     History of Changes
Other Study ID Numbers: 28.073-2
PR#0830A
IRB# 26.073-2
First Submitted: January 23, 2009
First Posted: January 27, 2009
Last Update Posted: September 16, 2009
Last Verified: September 2009

Keywords provided by California Pacific Medical Center Research Institute:
Naloxone
6β-Naltrexol
Opioid-dependent
Pharmacokinetics
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
Naloxone
Naltrexone
Lactulose
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists
Gastrointestinal Agents