Naltrexone and Adrenergic Agents to Reduce Heroin Use in Heroin Addicts

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Thomas R. Kosten, MD, Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT00142948
First received: September 1, 2005
Last updated: October 22, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention Phase
Heroin Dependence
Drug: Naltrexone
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Heroin Addiction Treatment: Naltrexone and Adrenergic Agents

Resource links provided by NLM:


Further study details as provided by Baylor College of Medicine:

Primary Outcome Measures:
  • Heroin relapse [ Time Frame: duration of study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 301
Study Start Date: February 2006
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Naltrexone
Naltrexone Oral 50 mgs daily
Drug: Naltrexone
naltrexone
Placebo Comparator: Placebo
1 to 1 comparison of Naltrexone to placebo
Drug: Placebo
placebo

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 of 7-14 days, participants will have a period of inpatient rehabilitation. During this 3- to 4-week inpatient stabilization period, patients will be screened for study participation. 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 monthly. 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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00142948

Locations
Russian Federation
Saint Petersburg Pavlov State Medical University
Saint Petersburg, Russian Federation
Sponsors and Collaborators
Baylor College of Medicine
Investigators
Principal Investigator: Thomas R. Kosten, MD Baylor College of Medicine
  More Information

No publications provided

Responsible Party: Thomas R. Kosten, MD, Professor, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00142948     History of Changes
Other Study ID Numbers: NIDA-18863, R01DA018863, DPMC
Study First Received: September 1, 2005
Last Updated: October 22, 2012
Health Authority: United States: Federal Government

Keywords provided by Baylor College of Medicine:
Heroin Abuse
Heroin Addiction

Additional relevant MeSH terms:
Heroin Dependence
Opioid-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Naltrexone
Heroin
Adrenergic Agents
Narcotic Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Analgesics
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 22, 2014