Naltrexone and Adrenergic Agents to Reduce Heroin Use in Heroin Addicts

Baylor College of Medicine

Status and phase

Completed

Phase 2

Conditions

Heroin Dependence

Treatments

Drug: Naltrexone

Drug: Placebo

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00142948

R01DA018863 (U.S. NIH Grant/Contract)

DPMC

NIDA-18863

Details and patient eligibility

About

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.

Full 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.

Enrollment

301 patients

Sex

All

Ages

18 to 40 years old

Volunteers

No Healthy Volunteers

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