Naltrexone and Adrenergic Agents to Reduce Heroin Use in Heroin Addicts
Heroin Addiction Treatment: Naltrexone and Adrenergic Agents
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
-
Saint Petersburg, Russian Federation
- Saint Petersburg Pavlov State Medical University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Naltrexone
Naltrexone Oral 50 mgs daily
|
naltrexone
|
|
PLACEBO_COMPARATOR: Placebo
1 to 1 comparison of Naltrexone to placebo
|
placebo
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Heroin relapse
Time Frame: duration of study
|
duration of study
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
HIV risk factors
Time Frame: baseline
|
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
|
months 6 and the 3- and 6-month follow-up evaluations
|
|
Adherence to medication
Time Frame: duration of study
|
duration of study
|
|
Heroin withdrawal symptoms
Time Frame: Month 6, and 3- and 6-month followup
|
Month 6, and 3- and 6-month followup
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NIDA-18863
- DPMC (Other Identifier: NIDA)
- R01DA018863 (NIH)
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