Naltrexone and Adrenergic Agents to Reduce Heroin Use in Heroin Addicts


Tracking Information

Start Date  ICMJEFebruary 2006
Estimated Primary Completion DateJuly 2010   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE 
 (submitted: February 19, 2008)
Heroin relapse [ Time Frame: duration of study ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures  ICMJE 
 (submitted: September 16, 2005)
Drug relapse; measured at Month 6
Change HistoryComplete list of historical versions of study NCT00142948 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE 
 (submitted: February 19, 2008)
  • HIV risk factors [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Psychiatric symptoms (measured at Month 6, and the 3- and 6-month follow-up evaluations) [ Time Frame: months 6 and the 3- and 6-month follow-up evaluations ] [ Designated as safety issue: No ]
  • Adherence to medication [ Time Frame: duration of study ] [ Designated as safety issue: No ]
  • Heroin withdrawal symptoms [ Time Frame: Month 6, and 3- and 6-month followup ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures  ICMJE 
 (submitted: January 19, 2006)
  • HIV risk factors
  • Psychiatric symptoms (measured at Month 6, and the 3- and 6-month follow-up evaluations)

Descriptive Information

Brief Title  ICMJENaltrexone and Adrenergic Agents to Reduce Heroin Use in Heroin Addicts
Official Title  ICMJEHeroin Addiction Treatment: Naltrexone and Adrenergic Agents
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 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.

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 blocking the "high" feeling produced by drugs and alcohol. Guanfacine, an antihypertensive medication, is currently used to manage the withdrawal symptoms in individuals undergoing opioid detoxification. While each of these medications is useful in the treatment of heroin addiction, a combination of the two drugs may be more effective than either medication alone. The purpose of this study is to compare the effectiveness of naltrexone, guanfacine, and a combination of naltrexone and guanfacine at reducing drug relapse in heroin addicts.

This study will enroll individuals addicted to heroin who have completed a prior detoxification program at one of two addiction treatment hospitals in St. Petersburg, Russian Federation. Upon completing the detoxification program, participants will be required to stay overnight at the clinic for a 3- to 4-week inpatient stabilization period. Once stabilized, participants will begin the 6-month treatment phase of the study. During this phase, they will be randomly assigned to receive one of the following drug combinations on a daily basis: 50 mg of naltrexone and guanfacine placebo; 1.0 mg of guanfacine and naltrexone placebo; 50 mg of naltrexone and 1.0 mg of guanfacine; or naltrexone placebo and guanfacine placebo. All participants will have a designated family member who will be responsible for supervising medication compliance. Study visits will occur twice a week. Participants will receive clinical management and medication compliance counseling at each visit; family members will also take part in the counseling sessions. Outcome measurements will include drug relapse, medication adherence, withdrawal symptoms, HIV risk factors, and psychiatric symptoms. Follow-up evaluations will occur 3 and 6 months following the end of treatment.

Study PhasePhase II
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Condition  ICMJEHeroin Dependence
Intervention  ICMJE
  • Drug: Naltrexone
    naltrexone
  • Drug: Placebo
    placebo
Study Arms / Comparison Groups
  • 1: Experimental
    Naltrexone
    Intervention: Drug: Naltrexone
  • 2: Placebo Comparator
    Intervention: Drug: Placebo

Recruitment Information

Estimated Enrollment  ICMJE280
Estimated Completion DateJuly 2010
Estimated Primary Completion DateJuly 2010   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
GenderBoth
Ages18 Years to 40 Years
Accepts Healthy VolunteersNo
Contacts  ICMJE 
Location Countries  ICMJERussian Federation

Administrative Information

NCT ID  ICMJENCT00142948
Responsible PartyThomas Kosten, MD, Baylor College of Medicine
Study ID Numbers  ICMJENIDA-18863, R01-DA018863, DPMC
Study Sponsor  ICMJENational Institute on Drug Abuse (NIDA)
Collaborators  ICMJEUS World Pharmacy
Investigators  ICMJE
Principal Investigator:Thomas R. Kosten, MDBaylor College of Medicine
Information Provided ByNational Institute on Drug Abuse (NIDA)