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

NCT02602795 | Completed DMC

• 1 other identifier: R34DA037797
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Opiate Dependence; Sexually Transmitted Diseases; HIV

Keywords

Opiate Dependence; Sexually Transmitted Diseases; HIV; Extended release naltrexone

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• Sex Risk Behavior

  6-months

• Drug Risk Behavior

  6-months

• HIV Risk Behavior

  6-months

Study Arms (3)

Distress Tolerance (DT)

EXPERIMENTAL

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

HIV/STI Intervention

ACTIVE COMPARATOR

Information Motivation Behavioral model based HIV/STI risk reduction intervention delivered in six 50-minute individual telehealth sessions.

Behavioral: Information Motivation Behavioral Model

Treatment As Usual (TAU)

NO INTERVENTION

Traditional treatment given to patients who elect to transition to XR-NTX at the treatment sites.

Interventions

Acceptance and Commitment Therapy BEHAVIORAL

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.

Distress Tolerance (DT)

Information Motivation Behavioral Model BEHAVIORAL

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.

HIV/STI Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rhode Island Hospital: lead

Study Sites (1)

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders; Sexually Transmitted Diseases

Interventions

Acceptance and Commitment Therapy; Information Motivation Behavioral Skills Model

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Communicable Diseases; Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Models, Psychological; Models, Theoretical; Investigative Techniques

Study Officials

• Susan E Ramsey, Ph.D.

  Rhode Island Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2015
• First Posted: November 11, 2015
• Study Start: December 1, 2015
• Primary Completion: January 1, 2018
• Study Completion: June 1, 2018
• Last Updated: August 29, 2018

Record last verified: 2017-04

Locations

US (1)