Status:
COMPLETED
Naltrexone and Adrenergic Agents to Reduce Heroin Use in Heroin Addicts
Lead Sponsor:
Baylor College of Medicine
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Heroin Dependence
Eligibility:
All Genders
18-40 years
Phase:
PHASE2
Brief Summary
Naltrexone is a medication that is currently used to treat drug and alcohol addiction. Guanfacine is a medication that is currently used to manage the withdrawal symptoms in individuals undergoing opi...
Detailed Description
Heroin addiction is a serious health problem with no available medical treatment for preventing relapse. Naltrexone is a medication that is currently used to treat substance addiction. It acts by bloc...
Eligibility Criteria
Inclusion
- Current primary diagnosis of heroin dependence, for at least 1 year prior to study entry
- High school graduate or higher education level
- Abstinence from drugs and alcohol for at least 1 week prior to study entry
- Negative urine and breathalyzer tests for alcohol and drugs
- No evidence of opioid dependence following narcan challenge
- At least one relative willing to participate in treatment, monitor administration of medications, assist in follow-up, and provide outcome data
- Stable address within St. Petersburg or nearest districts of Leningrad Region
- Able to provide a home telephone number where the participant may be reached
- If female, willing to use effective contraception throughout the study
Exclusion
- Low blood pressure, as determined by sitting blood pressure less than 90/50 mm Hg
- Clinically significant cognitive impairment, schizophrenia, paranoid disorder, bipolar disorder, or seizure disorder
- Advanced brain, heart, kidney, or liver disease
- Active tuberculosis
- Current febrile illness
- AIDS-defining illness
- Significant laboratory abnormality, including severe anemia, unstable diabetes, or liver function tests greater than three times above normal
- Pending legal issues that may entail a jail stay during the study
- Currently participating in another treatment study
- Currently participating in another substance abuse program
- Current use of a psychotropic medication
- Pregnant
- Pulse rate less than 50 bpm
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
301 Patients enrolled
Trial Details
Trial ID
NCT00142948
Start Date
February 1 2006
End Date
May 1 2011
Last Update
October 24 2012
Active Locations (1)
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1
Saint Petersburg Pavlov State Medical University
Saint Petersburg, Russia