Clinical trial NCT00675532: Testing a Primary Care Model for the Treatment of Opioid Dependence Using Long-acting Injectable Naltrexone (Vivitrol).
Official title: Testing a Primary Care Model for the Treatment of Opioid Dependence Using Long-acting Injectable Naltrexone (Vivitrol).
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Drug Dependence
Keywords: Opioids, vivitrol, naltrexone, primary care
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2008-05-09
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Male or female individuals, ages 18 and above, meeting current diagnostic and statistical manual (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).

Primary outcomes:
measure: Primary outcomes will be 1) percent of opioid negative urines and 2) treatment compliance as measured by attendance and time in treatment.
timeFrame: 12 weeks
Secondary outcomes:
measure: Secondary outcomes are opiate craving, opiate withdrawal symptoms, perceived stress scores, severity of addiction problems, and patient satisfaction.
timeFrame: 12 weeks
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale New Haven Hospital Primary Care Center
state: Connecticut
Study officials:
affiliation: Yale University
name: David Fiellin, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: