Status:
COMPLETED
Phase IIa Study of AV411, a Glial Activation Inhibitor, for Opioid Withdrawal
Lead Sponsor:
New York State Psychiatric Institute
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Opioid-Related Disorders
Eligibility:
All Genders
21-45 years
Phase:
PHASE2
Brief Summary
Repeated use and/or abuse of opioid medications is generally associated with a characteristic withdrawal syndrome that develops after cessation of drug administration. The present study is designed to...
Detailed Description
Opioid-induced cytokine release and glial activation has been proposed to directly contribute to the affective and physiological aspects of withdrawal. Furthermore, cytokine release following opioid a...
Eligibility Criteria
Inclusion
- Adults between the ages of 21 and 45
- Current dependence on heroin according to (Diagnostic and Statistical Manual) DSM-IV criteria
- Non-treatment seeking
Exclusion
- Female participants who are currently pregnant or breastfeeding. Lack of effective birth control 10 days before Study Day 1 (15 days prior to the first PET scan)
- Self-reported use of methadone, buprenorphine, or levo-alpha-acetylmethadol (LAAM) in the past 14 days
- Participants who have a positive history of neurological illness (including epilepsy) or those who have received anti-convulsant therapy during the past 5 years
- Liver disease requiring medication or medical treatment, and/or aspartate or alanine aminotransferase levels greater than 3 times the upper limit of normal
- Gastrointestinal or renal disease that would significantly impair absorption, metabolism or excretion of study drug, or require medication or medical treatment
- Neurological or psychiatric disorders including psychosis, bipolar disorder, organic brain disease, any seizure history or other disorders that require treatment or that could make study compliance difficult
- Positive tuberculosis (PPD) TB skin test along with a clinical history and chest X-ray indicative of active tuberculosis. (Individuals who have a positive PPD test and have a negative chest X-ray, are not symptomatic for tuberculosis, and do not require anti-tuberculosis therapy will be eligible to participate. Participants will be asked if they ever tested positive for tuberculosis. If so, they will not be given a PPD and a chest X-ray and clinical history will be used for evaluation purposes).
- Presence or positive history of severe medical illness or any cardiovascular disease or heart abnormality, such as low hemoglobin (Hb \< 13 g/dL in males, Hb \< 11 g/dL in females), or BP \> 150/90.
- Requirement for any of the following medications (current or within the past 4 weeks): psychotropics (including sedative/hypnotics, antidepressants, neuroleptics), anticonvulsants, antihypertensives, antiarrhythmics, or antiretroviral medications,. Participants on any current psychoactive prescription medications will be excluded.
- Current dependence (by DSM-IV criteria) on methadone, LAAM, or buprenorphine
- Participants for whom detoxification is not "clinically recommended" such as those with a significant history of overdose following detoxification
- Participation in an investigational drug study within the past 3 months
- Hypersensitivity to any of the medications used in this study
- Participants who are positive for HIV or chronic active hepatitis
- Metal implants or paramagnetic objects contained within the body which may interfere with the MRI scan, as determined in consultation with a neuroradiologist and according to the guidelines set forth in the following reference book commonly used by neuroradiologists: "Guide to MR procedures and metallic objects" Shellock Frank G., Lippincott Williams \& Wilkins Healthcare, Philadelphia, 2001.
- Lifetime exposure to radiation in the workplace, or participation in nuclear medicine procedures, including research protocols, in the past year
- Positive Allen Test indicating lack of collateral blood flow to hand
- History of Reynaud's syndrome
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00723177
Start Date
October 1 2008
End Date
June 1 2012
Last Update
December 5 2016
Active Locations (1)
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1
New York State Psychiatric Institute/Columbia University
New York, New York, United States, 10032