The purpose of this study is to evaluate the capacity of an opioid receptor antagonist, Naltrexone (N), or Lofexidine (L) which is a selective antihypertensive medication, and their combination (N+L) to prevent relapse to herion. Naltrexone prevents heroin''''s effects by binding to opioid receptors in the brain and is used to prevent relapse after detoxification. If has also been found to reduce the chances for relapse to alcohol dependence in alcoholics. Lofexidine is effective in treatment of hypertension, and may be helpful in herion detoxification and treating the anxiety. The combination of these two medications may work better than Naltrexone or Lofexidine alone.

Intervention	Phase
Drug: Heroin Dependence	Phase II

Further Study Details: 

This study will extend previous work at Pavlov Medical University with naltrexone and at Yale University with lofexidine, will provide information about the efficacy of these medications in preventing relapse in a cultural setting where agonist substitution therapy is not available

This double-blind placebo controlled randomized clinical trial aims to test two pharmacotherapies - Naltrexone and Lofexidine - used alone and in combination, as treatments for heroin addiction in St.

Petersburg, Russia, a cultural setting where agonist substitution therapy is not available. It will also provide data on the long term course of heroin addiction in this cultural setting.

This study will recruit recently detoxified opioid dependent patients from addiction treatment programs affiliated with St. Petersburg Pavlov State Medical University who meet DSM-IV criteria for heroin dependence who are eligible for naltrexone treatment. This project is a relapse prevention study that will evaluate four specific interventions that begin after detoxification and a brief period of inpatient stabilization (3-4 weeks) before randomization on to these two medications (delivered in an ambulatory months 2-6). The medication treatments will be combined with a standardized clinical management/compliance psychosocial treatment that also engages family members to support their efforts in medication adherence by the patient.

Subjects will be randomly assigned to one of four groups of 70 patients each: Naltrexone 50mg/day + Lofexidine placebo; Lofexidine 2.4mg/day + Naltrexone placebo; Naltrexone +Lofexidine; or Naltrexone placebo + Lofexidine placebo.

Ages Eligible for Study:  18 Years   -   40 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

Inclusion criteria

• Primary diagnosis of current Heroin Dependence, present for at least one year.
• Age between 18 and 40
• Education as high school graduate or above
• Abstinence from heroin and other substances of abuse for at least one week
• Negative urine toxicology and alcohol breath tests
• No evidence of opioid dependence following narcan challenge
• Not currently on psychotropic medication
• 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
• Home telephone number at which the patient can be reached
• Negative pregnancy test and use adequate contraception if of childbearing age
• Willingness and ability to give informed consent and otherwise participate

Exclusion Criteria:

Exclusion criteria

• Hypotensive individuals with sitting blood pressure below 90/50 mmHG.
• Clinically significant cognitive impairment, schizophrenia, paranoid disorder, bipolar disorder, or seizure disorder
• Advanced neurological, cardiovascular, renal, or hepatic disease
• Active tuberculosis or current febrile illness
• AIDS-defining illness
• Significant laboratory abnormality such as severe anemia, unstable diabetes, or liver function tests >3X above normal
• Pregnancy
• Pending legal charges with potential impending incarceration
• Concurrent participation in another treatment study
• Concurrent treatment in another substance abuse program

Please refer to this study by ClinicalTrials.gov identifier  NCT00142948

Russian Federation
      Saint Petersburg Pavlov State Medical University, Saint Petersburg,  Russian Federation

Study chairs or principal investigators

Thomas R Kosten, M.D.,  Principal Investigator,  Yale University   

Study ID Numbers:  NIDA-18863-1; R01-18863-1
Last Updated:  September 1, 2005
Record first received:  September 1, 2005
ClinicalTrials.gov Identifier:  NCT00142948
Health Authority: Russian federal service of surveillance on Public Health and Social Development.; Committeeon Ethics Affiliated to Federal Agency of the Control of Quality of Medicinal Products.
ClinicalTrials.gov processed this record on 2005-09-06