Naltrexone and Adrenergic Agents to Reduce Heroin Use in Heroin Addicts
Condition: Heroin Dependence
MeSH terms: Heroin Dependence
Study type: Interventional
Phase: Phase 2

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.
    

Intervention name(s): Naltrexone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): naltrexone; placebo
Intervention MeSH terms: Naltrexone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Heroin Abuse; Heroin Addiction