Naltrexone and Adrenergic Agents to Reduce Heroin Use in Heroin Addicts - Full Text View

Sponsors and Collaborators:	National Institute on Drug Abuse (NIDA) US World Pharmacy
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00142948

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 II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Heroin Addiction Treatment: Naltrexone and Adrenergic Agents

Resource links provided by NLM:

MedlinePlus related topics: Heroin

Drug Information available for: Naltrexone Naltrexone hydrochloride Diacetylmorphine Diacetylmorphine hydrochloride

U.S. FDA Resources

Further study details as provided by National Institute on Drug Abuse (NIDA):

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 ]

Estimated Enrollment:	280
Study Start Date:	February 2006
Estimated Study Completion Date:	July 2009
Estimated Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Naltrexone	Drug: Naltrexone naltrexone
2: Placebo Comparator	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, participants will be required to stay overnight at the clinic for a 3- to 4-week inpatient stabilization period. 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 a week. 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

Contacts and Locations

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

Locations

Russian Federation
Saint Petersburg Pavlov State Medical University	Recruiting
Saint Petersburg, Russian Federation
Contact: Evgeny Krupitsky, MD, PhD 203-932-5711 ext 7438

Sponsors and Collaborators

National Institute on Drug Abuse (NIDA)

US World Pharmacy

Investigators

Principal Investigator:

Thomas R. Kosten, MD

Baylor College of Medicine

More Information

No publications provided

Responsible Party:	Baylor College of Medicine ( Thomas Kosten, MD )
Study ID Numbers:	NIDA-18863, R01-18863, DPMC
Study First Received:	September 1, 2005
Last Updated:	March 10, 2009
ClinicalTrials.gov Identifier:	NCT00142948 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Institute on Drug Abuse (NIDA):

Heroin Abuse
Heroin Addiction

Study placed in the following topic categories:

Behavior, Addictive
Neurotransmitter Agents
Adrenergic Agents
Heroin Dependence
Heroin
Narcotic Antagonists
Central Nervous System Depressants
Disorders of Environmental Origin

Narcotics
Opioid-Related Disorders
Mental Disorders
Naltrexone
Substance-Related Disorders
Analgesics
Peripheral Nervous System Agents
Analgesics, Opioid

Additional relevant MeSH terms:

Neurotransmitter Agents
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Heroin Dependence
Heroin
Narcotic Antagonists
Physiological Effects of Drugs
Central Nervous System Depressants
Disorders of Environmental Origin
Narcotics
Opioid-Related Disorders

Pharmacologic Actions
Sensory System Agents
Mental Disorders
Therapeutic Uses
Naltrexone
Substance-Related Disorders
Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Analgesics, Opioid

ClinicalTrials.gov processed this record on July 02, 2009