Phase IIa Study of AV411, a Glial Activation Inhibitor, for Opioid Withdrawal
Completed · Phase 2 · Has a placebo group
Conditions studied: Opioid-Related Disorders
In brief
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 evaluate the effectiveness of AV411 to alter opioid-induced withdrawal symptoms.
Key facts
- Study ID
- NCT00723177
- Run by
- New York State Psychiatric Institute
- People needed
- 30
- Starts
- 2008-10-01
- Expected to finish
- 2012-06-01
- Last updated by the study team
- 2016-12-05
Who can join
Age: 21 and older, up to 45. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Adults between the ages of 21 and 45
- Current dependence on heroin according to (Diagnostic and Statistical Manual) DSM-IV criteria
- Non-treatment seeking
You may not qualify if…
- 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
Where it is running
- New York State Psychiatric Institute/Columbia University — New York, New York, United States
Full record on ClinicalTrials.gov
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