Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    feasibility study of extended-release naltrexone in drug court
Previous Study | Return to List | Next Study

Feasibility Study of Extended-release Naltrexone (Vivitrol) in Drug Court Settings (DC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02978417
Recruitment Status : Completed
First Posted : December 1, 2016
Last Update Posted : July 17, 2019
Sponsor:
Collaborators:
Laura and John Arnold Foundation
Alkermes, Inc.
FHR (Fellowship Health Resources, Inc.)
Drug Treatment Court (Wake County, NC)
Information provided by (Responsible Party):
Duke University

Brief Summary:

In preparation for a large-scale randomized controlled trial (RCT) of Vivitrol® effectiveness in drug courts, investigators propose a feasibility study in the Wake County, North Carolina drug court, where an estimated 50% of clients are opioid dependent.

Aim 1: Pilot RCT. Pilot-test the delivery of Vivitrol® treatment for 10-20 interested and eligible clients of the Wake County Drug Court.


Condition or disease Intervention/treatment Phase
Opioid-Related Disorders Drug: Naltrexone for extended-release injectable suspension Drug: Oral naltrexone Phase 4

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Feasibility Study for Testing the Effects of Extended-release Naltrexone (Vivitrol) on Recidivism and Other Participant Outcomes in Drug Court Settings
Actual Study Start Date : September 21, 2017
Actual Primary Completion Date : June 30, 2019
Actual Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Vivitrol
All drug court clients in the pilot RCT will receive standard psychosocial treatment for opioid dependence from FHR as part of their drug court program participation. Participants randomized to Vivitrol® will receive standard treatment along with monthly Vivitrol® injections administered by study staff at outpatient visits. Vivitrol® is naltrexone for extended-release injectable suspension. It is an injectable suspension containing 380 mg of naltrexone in a microsphere formulation and 4 mL diluent. The recommended dose of Vivitrol® is 380 mg delivered intramuscularly every 4 weeks or once a month. The injection should be administered by a healthcare provider as an intramuscular (IM) gluteal injection, alternating buttocks for each subsequent injection (see Links section of PRS for more information about Vivitrol).
Drug: Naltrexone for extended-release injectable suspension
Opioid-dependent Drug Court clients enrolled in the study will receive monthly injections of Vivitrol for up to 12 months if they continue to be medically eligible and willing.
Other Name: Vivitrol

Active Comparator: Oral naltrexone
Subjects randomized to oral naltrexone in addition to standard psychosocial treatment for opioid dependence from FHR as part of their drug court program participation. Oral naltrexone is the daily tablet formulation naltrexone that carries the same risks and benefits as the long-acting injectable formulation (Vivitrol®), except it does not have any of the risks related to injection (discomfort, potential for infection). Oral naltrexone is administered and provided by FHR to interested and eligible clients as part of the range of their usual care services.
Drug: Oral naltrexone
Opioid-dependent Drug Court clients enrolled in the study will receive prescriptions for oral naltrexone for up to 12 months if they continue to be medically eligible and willing.
Other Name: Revia




Primary Outcome Measures :
  1. New arrests [ Time Frame: 12 months ]
    New arrests (number of arrests, types of charges) during the 12-month study period. This information will be collected from administrative records.

  2. New incarcerations [ Time Frame: 12 months ]
    New incarcerations (number, length, and types of charges) during the 12-month study period. This information will be collected from administrative records.


Secondary Outcome Measures :
  1. Number of positive drug screens [ Time Frame: 12 months ]
    Number of times a client had a positive drug screen. This information will be collected from administrative records.

  2. Number of sanctions imposed by the court [ Time Frame: 12 months ]
    Number of sanctions imposed by the court (e.g., brief stays in jail). This information will be collected from administrative records.

  3. Number of missed court appointments [ Time Frame: 12 months ]
    Number of missed court appointments during the 12-month study period. This information will be collected from administrative records.

  4. Vivitrol participation [ Time Frame: 12 months ]
    Number/timing of Vivitrol injections, for Vivitrol arm only. This information will be collected from administrative records.

  5. Treatment participation (non-Vivitrol) [ Time Frame: 12 months ]
    Number/timing/type of other (non-Vivitrol) treatment participation for all participants in both arms of study. This information will be collected from administrative records.

  6. Change in subjective functioning: medical status [ Time Frame: Approximately 6 months ]
    Subjective assessment of medical status using the Addiction Severity Index (ASI) Lite (a single measure with multiple domains) collected via interviews at baseline and approximately six months.

  7. Change in subjective functioning: employment/support status [ Time Frame: Approximately 6 months ]
    Subjective assessment of employment and support status using the Addiction Severity Index (ASI) Lite (a single measure with multiple domains) collected via interviews at baseline and approximately six months.

  8. Change in subjective functioning: alcohol/drug use [ Time Frame: Approximately 6 months ]
    Subjective assessment of alcohol/drug use using the Addiction Severity Index (ASI) Lite (a single measure with multiple domains) collected via interviews at baseline and approximately six months.

  9. Change in subjective functioning: legal status [ Time Frame: Approximately 6 months ]
    Subjective assessment of legal status using the Addiction Severity Index (ASI) Lite (a single measure with multiple domains) collected via interviews at baseline and approximately six months.

  10. Change in subjective functioning: family/social relationships [ Time Frame: Approximately 6 months ]
    Subjective assessment of family and social relationships using the Addiction Severity Index (ASI) Lite (a single measure with multiple domains) collected via interviews at baseline and approximately six months.

  11. Change in subjective functioning: psychiatric status [ Time Frame: Approximately 6 months ]
    Subjective assessment of psychiatric status using the Addiction Severity Index (ASI) Lite (a single measure with multiple domains) collected via interviews at baseline and approximately six months.

  12. Treatment satisfaction [ Time Frame: Approximately 6 months ]
    Satisfaction with treatment as reported by subject in follow-up interview to occur about 6 months after the baseline interview.

  13. Treatment attitudes [ Time Frame: Approximately 6 months ]
    Attitudes toward Vivitrol and other forms of medication-assisted treatment for opioid dependence, to be measured via interview at baseline and approximately six months.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Client of Wake County Drug Treatment Court
  • Interested in medication-assisted treatment for opioid dependence
  • 18-65 years old
  • understands and speaks English
  • understands that study participation is fully voluntary, with no effect on court standing
  • willing and able to give written informed consent
  • has an opioid use disorder (DSM-5 diagnosis of moderate or severe opioid use disorder)
  • has at least 6 months remaining before anticipated Drug Court graduation
  • (if female) does not intend to become pregnant or breastfeeding during the study period and is willing to adhere to contraception requirements during the study period
  • is willing to adhere to the study requirements
  • Has at least 7-10 days without opioid use before beginning extended-release injectable naltrexone given that detoxification from opioids before initiating or resuming extended-release injectable naltrexone is necessary to prevent withdrawal.

Exclusion Criteria*:

  • Is pregnant (i.e., has a positive pregnancy test), planning to become pregnant, or breastfeeding during the study
  • Has a positive urine drug test for opioids, buprenorphine or methadone at the beginning of treatment and before each Vivitrol® injection
  • Has used any opioid drug within 10 days prior to treatment
  • Has a condition, disease state, previous medical history, or observed abnormalities (including physical examination, laboratory evaluation [e.g., kidney or liver function test result], or urinalysis finding) at screening that, in the opinion of the investigator, would preclude safe participation in the study or affect the ability of the subject to adhere to the protocol visit schedule, fulfill visit requirements, or would interfere with the study assessments, including, but not limited to, the following:

    • Uncontrolled hypertension, uncontrolled diabetes, renal disease/impairment, stroke, seizures or neurological disorder, cardiovascular (eg, endocarditis), neoplastic disease
    • Chronic pain condition requiring ongoing opioid analgesia
    • Aspartate aminotransferase or alanine aminotransferase value ≥3 times the upper limit of normal
    • Any contraindicated medical condition per the approved labeling for naltrexone
  • Has had a DSM-5 diagnosis within the past 12 months of other psychiatric conditions or disorders that, in the investigator's opinion, could interfere with participation in the study
  • Is currently physiologically dependent on any psychoactive substance (except caffeine, or tobacco) requiring medical intervention for detoxification
  • Has a history of hypersensitivity or adverse reaction to naltrexone, or naloxone
  • Has had significant suicidal ideation or behavior within the past year, as assessed with the Patient Health Questionnaire (PHQ-9)

    • Note about exclusion criteria: If, after joining the study, a subject has a positive drug test, becomes pregnant, or acquires another exclusion condition that would have prevented him/her from joining the study, he or she may remain in the study but will not be permitted to receive Vivitrol®. Study staff will continue to gather interview data and administrative data on any enrolled, willing subjects.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02978417


Locations
Layout table for location information
United States, North Carolina
Fellowship Health Resources (FHR)
Raleigh, North Carolina, United States, 27612
Sponsors and Collaborators
Duke University
Laura and John Arnold Foundation
Alkermes, Inc.
FHR (Fellowship Health Resources, Inc.)
Drug Treatment Court (Wake County, NC)
Investigators
Layout table for investigator information
Principal Investigator: Allison G Robertson, PhD, MPH Department of Psychiatry & Behavioral Sciences, Duke University School of Medicine

Additional Information:
Layout table for additonal information
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02978417    
Other Study ID Numbers: Pro00074507
69665 ( Other Grant/Funding Number: Laura and John Arnold Foundation )
First Posted: December 1, 2016    Key Record Dates
Last Update Posted: July 17, 2019
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Duke University:
Medication-assisted treatment
Drug Court
Pilot study
Opioid dependence
Criminal justice
Additional relevant MeSH terms:
Layout table for MeSH terms
Naltrexone
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Opioid-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Analgesics
Alcohol Deterrents
Narcotic Antagonists