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

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.

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.