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

Primary Purpose

Opiate Addiction

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
6β-Naltrexol escalating doses from 0.05-0.5 mg IV
Sponsored by
California Pacific Medical Center Research Institute
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Opiate Addiction focused on measuring Naloxone, 6β-Naltrexol, Opioid-dependent, Pharmacokinetics, peripheral effects of withdrawal, central effects of withdrawal

Eligibility Criteria

21 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • CPMC Addiction & Pharmacology Research Laboratory (APRL)

Outcomes

Primary Outcome Measures

- 6β-Naltrexol will have 13 hr half-life. Plasma collected
- 6β-Naltrexol pharmacokinetic profile in opioid-dependent population will be similar in non-opioid-dependent population. Plasma levels collected

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
6β-Naltrexol dose-dependent increases to reverse methadone-induced bowel dysfunction. Plasma levels and Hydrogen Breath Tests

Full Information

First Posted
January 23, 2009
Last Updated
September 14, 2009
Sponsor
California Pacific Medical Center Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT00829777
Brief Title
Safety Study of Intravenous 6β-Naltrexol (AIKO-150) in Opioid-Dependent Subjects
Acronym
AIKO-150
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.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
California Pacific Medical Center Research Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opiate Addiction
Keywords
Naloxone, 6β-Naltrexol, Opioid-dependent, Pharmacokinetics, peripheral effects of withdrawal, central effects of withdrawal

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
8 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
6β-Naltrexol escalating doses from 0.05-0.5 mg IV
Other Intervention Name(s)
Naloxone, 6β-Naltrexol, Lactulose
Intervention Description
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.
Primary Outcome Measure Information:
Title
- 6β-Naltrexol will have 13 hr half-life. Plasma collected
Time Frame
-0-24 hrs post dose
Title
- 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 Measure Information:
Title
-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
Title
6β-Naltrexol dose-dependent increases to reverse methadone-induced bowel dysfunction. Plasma levels and Hydrogen Breath Tests
Time Frame
0-8 hrs post dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John E Mendelson, MD
Organizational Affiliation
California Pacific Medical Center Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
CPMC Addiction & Pharmacology Research Laboratory (APRL)
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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