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Place of Low-Dose Naltrexone in Opiate Detoxification - 1 - Article


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Fall-Related Injuries


Clinical Trial: Place of Low-Dose Naltrexone in Opiate Detoxification - 1

This study is currently recruiting patients.
Verified by National Institute on Drug Abuse (NIDA) August 2005

Sponsored by: National Institute on Drug Abuse (NIDA)
Information provided by: National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier: NCT00135759

Purpose

There is a continuing search for more effective opiate detoxification treatments. The purpose of this study is to investigate the effects of very low doses of naltrexone in treating opioid dependent individuals.
Condition Intervention Phase
Heroin Dependence
Opioid-Related Disorders
Substance-Related Disorders
 Drug: Naltrexone
Phase II

MedlinePlus related topics:  Drug Abuse;   Heroin;   Prescription Drug Abuse

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study

Official Title: Place of Low-Dose Naltrexone in Opiate Detoxification

Further Study Details: 
Primary Outcomes: Addiction severity, Day 6; Withdrawl, Day 6

Although many different techniques for opiate detoxification have been employed, there is a continuing search for more effective approaches to reduce the duration and discomfort associated with opioid dependence. It has been shown that very low doses of naltrexone administered in the presence of opiates has analgesic and dependency reducing properties.The purpose of this study is to investigate the effects of very low doses of naltrexone in treating opioid dependent individuals, administered during methadone-tapering, opiate detoxification. In addition, this study will compare the effectiveness of two different dose regimens of naltrexone.

Participants in this double-blind study will be recruited among opioid dependent individuals receiving the standard pharmacological (drug?) protocol to control discomfort during a methadone tapering treatment in a 6 day inpatient detoxification program. Participiants will be randomly assigned to one of three groups. Two of the groups will be given naltrexone; group 1 will receive 0.125 mg each day, while group 2 will receive 0.250 mg each day. Group 3 will receive a placebo. Participants will be evaluated upon enrollment for the severity of their addiction to opiate and then daily for signs of withdrawl and salivary cortisol. In addition, participants will return for an evaluation and completion of a urine test for drugs of abuse at Day 1 following discharge. Daily evaluations will take 15 minutes to complete.

In addition, participants will participate in a telephone interview of about 20 minutes, at Day 7 following discharge. During the phone interview, participants will schedule an appointment to provide a final urine specimen for the detection of drugs of abuse.

Eligibility

Ages Eligible for Study:  18 Years   -   90 Years,  Genders Eligible for Study:  Both
Criteria

Inclusion Criteria:

  • Current DSM-IV diagnosis of opiate dependence
  • Reads and understands English

Exclusion Criteria:

  • Serious medical disorders (e.g., uncontrolled hypertension, acute or chronic active hepatitis, kidney failure, uncontrolled diabetes)
  • Psychiatric conditions that require intensive services (e.g., depression with suicidal ideation, psychosis)
  • Mental retardation or other disorder that might limit ability to give informed consent
  • Pregnant

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00135759

Neena Ajwani      (919)477-1216  Ext. 4    neena.ajwani@duke.edu

North Carolina
      Duke University, Durham,  North Carolina,  27704,  United States; Recruiting
Neena Ajwani  919-477-1216  Ext. 4    neena.ajwani@duke.edu 

Study chairs or principal investigators

Paolo Mannelli, M.D.,  Principal Investigator,  Thomas Jefferson University   

More Information

Study ID Numbers:  NIDA-15469-1; R21-15469-1
Last Updated:  August 25, 2005
Record first received:  August 23, 2005
ClinicalTrials.gov Identifier:  NCT00135759
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-08-30


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