Naltrexone and Adrenergic Agents to Reduce Heroin Use in Heroin Addicts

• Status: Completed
• Trial end date: 2011-05-01
• Target enrollment: 0
• Participant gender: All

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 opioid detoxification. A combination of these two medications may be beneficial in reducing heroin use in individuals addicted to heroin. This study will evaluate the effectiveness of naltrexone and guanfacine, alone and in combination, at reducing heroin use in heroin addicts.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Baylor College of Medicine
• Collaborator: National Institute on Drug Abuse (NIDA)
• Treatments: Adrenergic Agents; Heroin; Naltrexone

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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