Opiate DependenceNCT02602795
Distress Tolerance and HIV Prevention With XR-NTX Initiation in Opioid Dependence
A study testing Acceptance and Commitment Therapy and Information Motivation Behavioral Model in people with Opiate Dependence and Sexually Transmitted Diseases, run by Rhode Island Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opiate Dependence, Sexually Transmitted Diseases, HIV
- What is being tested?
- Acceptance and Commitment Therapy and Information Motivation Behavioral Model
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2015to Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Rhode Island Hospital
Providence, Rhode Island, 02903
About this study
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.
Read the 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.
- Conditions
- Opiate Dependence, Sexually Transmitted Diseases, HIV
- Being tested
- Acceptance and Commitment Therapy, Information Motivation Behavioral Model
- Keywords
- Opiate Dependence, Sexually Transmitted Diseases, HIV, Extended release naltrexone
- Medical subject headings
- Opioid-Related Disorders, Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance and Commitment TherapyBehavioural
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.
Information Motivation Behavioral ModelBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful Detoxification
The investigators will compare the odds of successful detoxification, or receipt of the first XR-NTX injection, between treatment groups.
Measured: 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.
Measured: 6-months
Opioid Drug Use Outcomes
Percent of opioid use days compared between the groups
Measured: 6-months
Illicit Drug Use Outcomes
Percent of illicit drug use days compared between the groups
Measured: 6-months
Secondary outcomes (3)
Sex Risk Behavior
The investigators will compare the occurrence of sex risk behavior between the treatment groups.
Measured: 6-months
Drug Risk Behavior
The investigators will compare the occurrence of drug risk behavior between the treatment groups.
Measured: 6-months
HIV Risk Behavior
The investigators will compare the occurrence of overall HIV risk behavior between the treatment groups.
Measured: 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2015 (estimated)
- Study startDec 2015
- Primary completionJan 2018
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opiate DependenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rhode Island Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Susan E Ramsey, Ph.D., Principal investigator, Rhode Island Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02602795
- Sponsor's protocol ID
- R34DA037797
- Status last verified
- Apr 2017
- First submitted
- 9 Nov 2015
- Last updated
- 29 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Distress Tolerance and HIV Prevention With XR-NTX Initiation in Opioid Dependence
- ClinicalTrials.gov ID
- NCT02602795
- Acronym / sponsor ID
- R34DA037797
- Conditions
- Opiate Dependence, Sexually Transmitted Diseases, HIV
- Keywords
- Opiate Dependence, Sexually Transmitted Diseases, HIV, Extended release naltrexone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Rhode Island HospitalUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 11 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Distress Tolerance (DT) | Experimental | Behavioral: Acceptance and Commitment TherapyAcceptance and Commitment Therapy based Distress Tolerance (DT) intervention to facilitate opioid detoxification delivered in six 50-minute individual telehealth sessions. |
| HIV/STI Intervention | Active comparator | Behavioral: Information Motivation Behavioral ModelInformation Motivation Behavioral model based HIV/STI risk reduction intervention delivered in six 50-minute individual telehealth sessions. |
| Treatment As Usual (TAU) | No intervention | –Traditional treatment given to patients who elect to transition to XR-NTX at the treatment sites. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acceptance and Commitment TherapyThe 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. | Behavioural | Distress Tolerance (DT) |
| Information Motivation Behavioral ModelThis 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. | Behavioural | HIV/STI Intervention |
Primary outcome
Successful Detoxification
Time frame: 6-months
The investigators will compare the odds of successful detoxification, or receipt of the first XR-NTX injection, between treatment groups.
Number of XR-NTX Injections Received
Time frame: 6-months
The treatment groups will be compared on the number of XR-NTX injections received during follow-up.
Opioid Drug Use Outcomes
Time frame: 6-months
Percent of opioid use days compared between the groups
Illicit Drug Use Outcomes
Time frame: 6-months
Percent of illicit drug use days compared between the groups
3 secondary outcomes
Sex Risk Behavior
Time frame: 6-months
Drug Risk Behavior
Time frame: 6-months
HIV Risk Behavior
Time frame: 6-months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan E Ramsey, Ph.D. principal investigator
Rhode Island Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acceptance and Commitment Therapy and Information Motivation Behavioral Model in people with Opiate Dependence and Sexually Transmitted Diseases, run by Rhode Island Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful Detoxification (time frame: 6-months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2018.