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

Sponsor:	California Pacific Medical Center Research Institute
Information provided by:	California Pacific Medical Center Research Institute
ClinicalTrials.gov Identifier:	NCT00829777

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 I

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver) 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:

Drug Information available for: Naloxone hydrochloride Naloxone Lactulose

U.S. FDA Resources

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 ] [ 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 ]

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 ] [ 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 ]

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: 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

Ages Eligible for Study:	21 Years to 45 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received:	January 23, 2009
Last Updated:	September 14, 2009
Health Authority:	United States: Food and Drug Administration

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:

Behavior, Addictive
Opioid-Related Disorders
Compulsive Behavior
Impulsive Behavior
Substance-Related Disorders
Mental Disorders
Lactulose
Naloxone
Analgesics, Opioid
Gastrointestinal Agents

Therapeutic Uses
Pharmacologic Actions
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Analgesics
Central Nervous System Depressants

ClinicalTrials.gov processed this record on February 09, 2012