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Naltrexone and Adrenergic Agents to Reduce Heroin Use in Heroin Addicts

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00142948
Recruitment Status : Completed
First Posted : September 2, 2005
Last Update Posted : October 24, 2012
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Thomas R. Kosten, MD, Baylor College of Medicine

Tracking Information
First Submitted Date  ICMJE September 1, 2005
First Posted Date  ICMJE September 2, 2005
Last Update Posted Date October 24, 2012
Study Start Date  ICMJE February 2006
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 19, 2008)
Heroin relapse [ Time Frame: duration of study ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 19, 2008)
  • HIV risk factors [ Time Frame: baseline ]
  • 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 ]
  • Adherence to medication [ Time Frame: duration of study ]
  • Heroin withdrawal symptoms [ Time Frame: Month 6, and 3- and 6-month followup ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Naltrexone and Adrenergic Agents to Reduce Heroin Use in Heroin Addicts
Official Title  ICMJE Heroin 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 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Heroin Dependence
Intervention  ICMJE
  • Drug: Naltrexone
    naltrexone
  • Drug: Placebo
    placebo
Study Arms  ICMJE
  • Experimental: Naltrexone
    Naltrexone Oral 50 mgs daily
    Intervention: Drug: Naltrexone
  • Placebo Comparator: Placebo
    1 to 1 comparison of Naltrexone to placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 22, 2012)
301
Original Enrollment  ICMJE
 (submitted: September 1, 2005)
0
Actual Study Completion Date  ICMJE May 2011
Actual Primary Completion Date May 2011   (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
  • Pulse rate less than 50 bpm
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Russian Federation
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00142948
Other Study ID Numbers  ICMJE NIDA-18863
R01DA018863 ( U.S. NIH Grant/Contract )
DPMC
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Thomas R. Kosten, MD, Baylor College of Medicine
Study Sponsor  ICMJE Baylor College of Medicine
Collaborators  ICMJE National Institute on Drug Abuse (NIDA)
Investigators  ICMJE
Principal Investigator: Thomas R. Kosten, MD Baylor College of Medicine
PRS Account Baylor College of Medicine
Verification Date October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP