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Testing a Primary Care Model for the Treatment of Opioid Dependence Using Long-Acting Injectable Naltrexone (Vivitrol).
This study is not yet open for participant recruitment.
Verified by Yale University, January 2009
First Received: May 7, 2008   Last Updated: January 20, 2009   History of Changes
Sponsored by: Yale University
Information provided by: Yale University
ClinicalTrials.gov Identifier: NCT00675532
  Purpose

In opioid dependent patients treated with long-acting injectable naltrexone (Vivitrol ®), we will compare the efficacy of a primary care model of counseling (Condition 1) versus individualized cognitive-behavioral psychotherapy (Condition 2) for the treatment of opioid dependence. Treatment will last 12 weeks, and participants will be given 380mg of naltrexone per injection (3 injections in total; each lasting 4 weeks).

Primary outcomes will be 1) percent of opioid negative urines and 2) treatment compliance as measured by attendance and time in treatment. Secondary outcomes are opiate craving, opiate withdrawal symptoms, perceived stress scores, severity of addiction problems, and patient satisfaction. Findings will elucidate whether injectable, long-acting naltrexone would be safe and effective in a primary care setting where medication would be administered in the absence of traditional cognitive-behavioral psychotherapy and indicate whether cognitive-behavioral psychotherapy adds to treatment effects above and beyond primary care counseling. If positive, this small controlled study will provide effect size estimates for a larger trial to assess Vivitrol ® in a primary care setting.


Condition Intervention
Drug Dependence
Behavioral: Primary Care Counseling
Behavioral: Cognitive-behavioral psychotherapy

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title: Testing a Primary Care Model for the Treatment of Opioid Dependence Using Long-Acting Injectable Naltrexone (Vivitrol).

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • Primary outcomes will be 1) percent of opioid negative urines and 2) treatment compliance as measured by attendance and time in treatment. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary outcomes are opiate craving, opiate withdrawal symptoms, perceived stress scores, severity of addiction problems, and patient satisfaction. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: May 2009
Estimated Study Completion Date: August 2011
Estimated Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Primary Care Counseling
Behavioral: Primary Care Counseling
Subjects in this condition will attend bi-weekly 15 minute sessions with the study nurse for primary care counseling which is a brief manual-guided, medically focused counseling approach to the treatment of opioid dependent individuals seen in primary care settings. The brief counseling sessions involve repeated support for and monitoring of medication compliance, and the provision of advice regarding established methods for coping with psychological and social factors that lead to drug use.
2: Experimental
Cognitive-behavioral psychotherapy
Behavioral: Cognitive-behavioral psychotherapy

Subjects in the CBT condition will participate in bi-weekly 50-minute-long individualized cognitive-behavioral psychotherapy sessions with a CBT trained clinician. The general purpose of the therapy is to: (1) acquire information about important concepts and aspects of recovery from opioid addiction; (2) increase self-awareness of specific problems and issues in relation to addiction and recovery, and (3) learn new coping skills to deal with problems contributing to or resulting from the addiction and to improve overall psychosocial functioning.

The primary focus of this approach is to provide patients with frequent supportive contact and to teach cognitive-behavioral relapse prevention skills.


  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female individuals, ages 18 and above, meeting current DSM-IV criteria for opioid dependence.
  • Subject has voluntarily given informed consent and signed the informed consent document.
  • Able to read English and complete study evaluations.

Exclusion Criteria:

  • Regular use of benzodiazepines.
  • Psychotic or otherwise severely psychiatrically disabled (i.e., suicidal, homicidal, current mania);
  • Significant underlying medical conditions such as cerebral, renal, thyroid or cardiac pathology which in the opinion of study physician would preclude patient from fully cooperating or be of potential harm during the course of the study;
  • Abstinent from opiates for more than four weeks prior to naltrexone initiation.
  • Medical problems that would preclude naltrexone treatment, such as laboratory evidence of significant hepato-cellular injury as evidenced by abnormal liver enzyme tests including SGOT and SGPT (> three times normal) or elevated bilirubin levels), and a history of cirrhosis.
  • Women who are pregnant, nursing or refuse to use a reliable form of birth control (as assessed by pregnancy tests during initial evaluation for naltrexone, and every two weeks during the course of the study).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00675532

Contacts
Contact: Scott M. Hyman, Ph.D. 203 974-5736 scott.hyman@yale.edu
Contact: David Fiellin, MD (203) 688-2984 david.fiellin@yale.edu

Locations
United States, Connecticut
Yale New Haven Hospital Primary Care Center
New Haven, Connecticut, United States, 06519
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: David Fiellin, Ph.D. Yale School of Medicine
  More Information

No publications provided

Responsible Party: Yale University School of Medicine ( David Fiellin, MD Associate Professor of Medicine )
Study ID Numbers: Yale HIC #0708002942
Study First Received: May 7, 2008
Last Updated: January 20, 2009
ClinicalTrials.gov Identifier: NCT00675532     History of Changes
Health Authority: United States: Institutional Review Board;   United States: Federal Government

Keywords provided by Yale University:
Opioids, vivitrol, naltrexone, primary care

Study placed in the following topic categories:
Mental Disorders
Narcotic Antagonists
Naltrexone
Substance-Related Disorders
Central Nervous System Depressants
Disorders of Environmental Origin
Narcotics
Peripheral Nervous System Agents
Analgesics
Analgesics, Opioid

Additional relevant MeSH terms:
Narcotic Antagonists
Physiological Effects of Drugs
Central Nervous System Depressants
Disorders of Environmental Origin
Pharmacologic Actions
Mental Disorders
Sensory System Agents
Therapeutic Uses
Naltrexone
Substance-Related Disorders
Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Analgesics, Opioid

ClinicalTrials.gov processed this record on September 10, 2009