Naltrexone and Adrenergic Agents to Reduce Heroin Use in Heroin Addicts

NCT00142948 | Completed Phase 2 DMC

• 3 other identifiers: NIDA-18863R01DA018863DPMC
• Study Type: interventional
• Target: 301
• Locations: 1 country
• Sites: 1

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.

Conditions

Heroin Dependence

Keywords

Heroin Abuse; Heroin Addiction

Outcome Measures

Primary Outcomes (1)

• Heroin relapse

  duration of study

Secondary Outcomes (4)

• HIV risk factors

  baseline

• Psychiatric symptoms (measured at Month 6, and the 3- and 6-month follow-up evaluations)

  months 6 and the 3- and 6-month follow-up evaluations

• Adherence to medication

  duration of study

• Heroin withdrawal symptoms

  Month 6, and 3- and 6-month followup

Study Arms (2)

Naltrexone

EXPERIMENTAL

Naltrexone Oral 50 mgs daily

Drug: Naltrexone

Placebo

PLACEBO COMPARATOR

1 to 1 comparison of Naltrexone to placebo

Drug: Placebo

Interventions

Naltrexone DRUG

naltrexone

Naltrexone

Placebo DRUG

placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Baylor College of Medicine: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Saint Petersburg Pavlov State Medical University

Saint Petersburg, Russia

Location

MeSH Terms

Conditions

Heroin Dependence

Interventions

Naltrexone

Condition Hierarchy (Ancestors)

Opioid-Related Disorders; Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Thomas R. Kosten, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 1, 2005
• First Posted: September 2, 2005
• Study Start: February 1, 2006
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: October 24, 2012

Record last verified: 2012-10

Locations

RU (1)