Distress Tolerance and HIV Prevention With XR-NTX Initiation in Opioid Dependence

Before starting treatment with XR-NTX, a medication that blocks the positive effects of opioids and helps people stay off opioids, individuals who are dependent on opioids first have to endure a difficult withdrawal process. This study aims to develop and test an intervention to help people who are opioid dependent successfully complete that transition; the investigators will also develop and test a comparison condition aimed at reducing HIV risk behavior.

Study Overview

• Status: Completed
• Conditions: Sexually Transmitted Diseases; HIV; Opiate Dependence
• Intervention / Treatment: Behavioral: Acceptance and Commitment Therapy; Behavioral: Information Motivation Behavioral Model

Detailed Description

Opioid dependence is a serious and increasingly pervasive problem. Opioid dependent individuals are at significantly increased risk for a wide range of physical and psychological problems including HIV and STIs. Extended-release naltrexone (XR-NTX) is an effective treatment for opioid dependence, but it requires that opioid-dependent individuals be completely opioid-free prior to its initiation to avoid precipitated withdrawal. The great majority of individuals attempting to cease opioid use will relapse before initiation of XR-NTX because of opioid withdrawal symptoms during detoxification. Distress Tolerance (DT) focused psychosocial interventions are well suited to address the clinical phenomena experienced by individuals withdrawing from opioids.

The purpose of this project is to develop a DT intervention to improve detoxification outcomes and an active comparison intervention targeting HIV and STI (HIV/STI) risk behavior. The DT intervention will be adapted from Acceptance and Commitment Therapy (ACT). The HIV/STI risk behavior intervention will target behaviors that put patients at risk for HIV and STIs including unprotected sex and needle sharing, as well as promoting regular HIV testing. Both interventions will be delivered through a telehealth videoconferencing system. If the HIV/STI intervention is found to result in reduced HIV/STI risk behavior and more frequent HIV testing, relative to the DT intervention, the investigators will incorporate its components into the DT intervention prior to launching a large-scale clinical trial. The long-term objective of this research program is to improve substance use and HIV/STI outcomes for opioid dependent individuals attempting to cease opioid use.

In Phase 1 of this project, the investigators will develop and pilot a DT intervention for individuals transitioning to XR-NTX and a time-matched HIV/STI risk reduction comparison intervention; both will be developed using an iterative process of piloting and modification based on data collected from pilot participants. In Phase 2, opioid dependent individuals transitioning to XR-NTX will be randomly assigned to DT, HIV/STI, or Treatment-As-Usual. All patients will receive medication assisted detoxification from the study recruitment site. It is expected that, as a result of this project, the investigators will have developed a well-specified and novel DT intervention tailored to meet the needs of opioid dependent patients transitioning to XR-NTX, the efficacy of which can be further tested in future Stage II randomized controlled trials. If found to be efficacious, this intervention will serve as an effective means of facilitating detoxification and opioid antagonist initiation, reducing the individual and societal burden due to opioid dependence.

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Rhode Island Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Must (1) meet Diagnostic and Statistical Manual of Mental Disorders-IV Lifetime criteria for Opioid Dependence, (2) not plan to receive opioid agonist treatment or opioid analgesics, (3) have no medical need for opioid pain medication, (4) have Alanine Transaminase and Aspartate Aminotransferase < 150, and (5) have platelets > 90.

Exclusion Criteria:

• Must not (1) be currently psychotic, (2) have current drug or alcohol dependence that requires medical detoxification or a higher level of care that would interfere with study participation, (3) be pregnant or lactating, (4) have acute hepatitis or liver failure, (5) have a bleeding disorder, or (6) be allergic to XR-NTX components.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Distress Tolerance (DT); Acceptance and Commitment Therapy based Distress Tolerance (DT) intervention to facilitate opioid detoxification delivered in six 50-minute individual telehealth sessions.	Behavioral: Acceptance and Commitment Therapy; The intervention is based on Acceptance and Commitment Therapy and will be tailored to help participants develop target adaptive responses to negative affect and other negative internal stimuli related to opioid detoxification.
Active Comparator: HIV/STI Intervention; Information Motivation Behavioral model based HIV/STI risk reduction intervention delivered in six 50-minute individual telehealth sessions.	Behavioral: Information Motivation Behavioral Model; This intervention is based on the Information Motivation Behavior model for HIV/STI risk reduction and is tailored to more directly address HIV/STI risk among opioid dependent patients.
No Intervention: Treatment As Usual (TAU); Traditional treatment given to patients who elect to transition to XR-NTX at the treatment sites.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Successful Detoxification	The investigators will compare the odds of successful detoxification, or receipt of the first XR-NTX injection, between treatment groups.	6-months
Number of XR-NTX Injections Received	The treatment groups will be compared on the number of XR-NTX injections received during follow-up.	6-months
Opioid Drug Use Outcomes	Percent of opioid use days compared between the groups	6-months
Illicit Drug Use Outcomes	Percent of illicit drug use days compared between the groups	6-months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sex Risk Behavior	The investigators will compare the occurrence of sex risk behavior between the treatment groups.	6-months
Drug Risk Behavior	The investigators will compare the occurrence of drug risk behavior between the treatment groups.	6-months
HIV Risk Behavior	The investigators will compare the occurrence of overall HIV risk behavior between the treatment groups.	6-months

Collaborators and Investigators

• Sponsor: Rhode Island Hospital
• Investigators: Principal Investigator: Susan E Ramsey, Ph.D., Rhode Island Hospital

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (Actual): January 1, 2018
• Study Completion (Actual): June 1, 2018

Study Registration Dates

• First Submitted: November 9, 2015
• First Submitted That Met QC Criteria: November 10, 2015
• First Posted (Estimate): November 11, 2015

Study Record Updates

• Last Update Posted (Actual): August 29, 2018
• Last Update Submitted That Met QC Criteria: August 28, 2018
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: HIV; Opiate Dependence; Sexually Transmitted Diseases; Extended release naltrexone
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Pathologic Processes; Substance-Related Disorders; Infections; Communicable Diseases; Disease Attributes; Narcotic-Related Disorders; Opioid-Related Disorders; Sexually Transmitted Diseases
• Other Study ID Numbers: R34DA037797 (U.S. NIH Grant/Contract)