Opiate AddictionPhase 1AIKO-150NCT00829777
Safety Study of Intravenous 6β-Naltrexol (AIKO-150) in Opioid-Dependent Subjects
A Phase 1 study testing 6β-Naltrexol escalating doses from 0.05-0.5 mg IV in people with Opiate Addiction, run by California Pacific Medical Center Research Institute at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of intravenous 6β-Naltrexol administered to opiate dependent subjects Read more about this study
- Who is it for?
- Ages 21 to 45 years
- Conditions the study is for
- Opiate Addiction
- What is being tested?
- 6β-Naltrexol escalating doses from 0.05-0.5 mg IV
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to Sep 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Opiate dependent males and females age 21-45 on stable doses of methadone
- Fluent English speaker
- Willing and able to give written consent
Who cannot join
- Pregnancy or lactation
- FOR MORE DETAILS CONTACT THE RESEARCH CLINIC.
Trial locations and contacts
1 site in 1 country.
United States1 site
CPMC Addiction & Pharmacology Research Laboratory (APRL)
San Francisco, California, 94110
About this study
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.
The purpose of this study is to evaluate the safety and efficacy of intravenous 6β-Naltrexol administered to opiate dependent subjects
- Conditions
- Opiate Addiction
- Being tested
- 6β-Naltrexol escalating doses from 0.05-0.5 mg IV
- Keywords
- Naloxone, 6β-Naltrexol, Opioid-dependent, Pharmacokinetics, peripheral effects of withdrawal, central effects of withdrawal
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
6β-Naltrexol escalating doses from 0.05-0.5 mg IVDrug
Also called Naloxone, 6β-Naltrexol, Lactulose
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
- 6β-Naltrexol will have 13 hr half-life. Plasma collected
Measured: -0-24 hrs post dose
- 6β-Naltrexol pharmacokinetic profile in opioid-dependent population will be similar in non-opioid-dependent population. Plasma levels collected
Measured: 0-8 hrs post dose
Secondary outcomes (2)
-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
Measured: 0-8 hrs post dose
6β-Naltrexol dose-dependent increases to reverse methadone-induced bowel dysfunction. Plasma levels and Hydrogen Breath Tests
Measured: 0-8 hrs post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2009 (estimated)
- Study startMar 2009
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opiate AddictionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- California Pacific Medical Center Research Institute
- Sponsor type
- University, hospital or other
- Investigators
- John E Mendelson, MD, Principal investigator, California Pacific Medical Center Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00829777
- Sponsor's protocol ID
- 28.073-2
- Other IDs
- PR#0830A, IRB# 26.073-2
- Acronym
- AIKO-150
- Status last verified
- Sep 2009
- First submitted
- 23 Jan 2009
- Last updated
- 16 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00829777
- Acronym / sponsor ID
- AIKO-150 / 28.073-2
- Conditions
- Opiate Addiction
- Keywords
- Naloxone, 6β-Naltrexol, Opioid-dependent, Pharmacokinetics, peripheral effects of withdrawal, central effects of withdrawal
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- California Pacific Medical Center Research InstituteUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 27 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety and efficacy of intravenous 6β-Naltrexol administered to opiate dependent subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, care provider)
Who may qualify
- Ages
- 21 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Opiate dependent males and females age 21-45 on stable doses of methadone
- Fluent English speaker
- Willing and able to give written consent
Key exclusion criteria (2 listed)
- Pregnancy or lactation
- FOR MORE DETAILS CONTACT THE RESEARCH CLINIC.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 6β-Naltrexol escalating doses from 0.05-0.5 mg IVAlso: Naloxone, 6β-Naltrexol, LactuloseDrug: 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. | Drug | – |
Primary outcome
- 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
2 secondary outcomes
-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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John E Mendelson, MD principal investigator
California Pacific Medical Center Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 6β-Naltrexol escalating doses from 0.05-0.5 mg IV in people with Opiate Addiction, run by California Pacific Medical Center Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
- 6β-Naltrexol will have 13 hr half-life. Plasma collected (time frame: -0-24 hrs post dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2009.