Opioid DependencePhase 3TRUSTNCT01556087
Distress Tolerance and Buprenorphine
A Phase 3 study testing Distress Tolerance and Health Education in people with Opioid Dependence, run by Butler Hospital at 1 site in United States.
Trial summary
The investigators propose that inability to tolerate the distress of opioid withdrawal and the negative affect associated with early abstinence are key factors in early illicit opioid lapse and subsequent buprenorphine treatment drop-out. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Opioid Dependence
- What is being tested?
- Distress Tolerance and Health Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to Aug 2015
- Phase
- Phase 3
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- initiating buprenorphine treatment (which requires meeting current criteria for a DSM-IV diagnosis of opioid dependence)
- plan to remain on buprenorphine for at least three months
- age between 18 and 65 years
- if female of childbearing potential -- must be using adequate contraception (an intrauterine device, oral contraceptive, depot contraceptive, a barrier method "every time," or hysterectomy) as assessed by the study physician
- has at least two persons they regularly contact and can provide contact information for them
- speaks English sufficiently to understand instructions and assessments.
Who cannot join
- current methadone maintenance treatment program participation
- medically necessary prescription opioid treatment (e.g., for chronic pain)
- current criteria for a DSM-IV diagnosis of substance dependence for sedative/hypnotic drugs, alcohol, stimulants, cocaine, inhalants, hallucinogens
- a diagnosis of organic brain disorder, bipolar disorder, schizophrenia, schizo-affective, schizophreniform, or paranoid disorder, or major depression (subjects who meet criteria for "substance-induced mood disorder," or dysthymia only will not be excluded)
- current suicidality on the Modified Scale for Suicidal Ideation
- use of daily psychotropic, antidepressant, or anxiolytic medication
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- evidence of neuropsychological dysfunction as assessed by the study physician with confirmation with the Folstein Mini-Mental Status Examination
- anticipated major painful event (significant surgical procedure) in the coming 6 months
- probation/parole requirements that might interfere with protocol participation
- history of allergic reaction to buprenorphine or naloxone.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Distress Tolerance and Reducing Early Relapse in Buprenorphine Patients
The investigators propose that inability to tolerate the distress of opioid withdrawal and the negative affect associated with early abstinence are key factors in early illicit opioid lapse and subsequent buprenorphine treatment drop-out. Our intervention aimed at increasing distress tolerance is designed to increase treatment adherence.
- Conditions
- Opioid Dependence
- Being tested
- Distress Tolerance, Health Education
- Keywords
- opioids, distress tolerance, buprenorphine
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Distress ToleranceBehavioural
7 individual sessions aimed at increasing distress tolerance skills
Health EducationBehavioural
7 individual sessions with didactic health education information
| Study group | Role | What they receive |
|---|---|---|
| Distress Tolerance | Experimental | 7 sessions aimed at increasing distress tolerance skills Receives: Behavioral: Distress Tolerance |
| Health Education | Placebo comparator | 7 didactic health education sessions Receives: Behavioral: Health Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
the Client Satisfaction Questionnaire-8
assess patient satisfaction with services
Measured: 4 months
buprenorphine treatment adherence
adherence to buprenorphine treatment, which includes opioid use and risk behaviors, will be assessed
Measured: 4 months
Secondary outcomes (1)
distress tolerance persistence
mechanisms hypothesized to mediate the relationship between DT treatment and improved buprenorphine outcomes will be assessed
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionFeb 2014
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Butler Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Stein, MD, Butler Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01556087
- Sponsor's protocol ID
- DA032767
- Acronym
- TRUST
- Status last verified
- Sep 2015
- First submitted
- 5 Mar 2012
- Last updated
- 10 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Distress Tolerance and Reducing Early Relapse in Buprenorphine Patients
- ClinicalTrials.gov ID
- NCT01556087
- Acronym / sponsor ID
- TRUST / DA032767
- Conditions
- Opioid Dependence
- Keywords
- opioids, distress tolerance, buprenorphine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Butler HospitalUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Feb 2014 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 16 Mar 2012 (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.
The investigators propose that inability to tolerate the distress of opioid withdrawal and the negative affect associated with early abstinence are key factors in early illicit opioid lapse and subsequent buprenorphine treatment drop-out. Our intervention aimed at increasing distress tolerance is designed to increase treatment adherence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Distress Tolerance | Experimental | Behavioral: Distress Tolerance7 sessions aimed at increasing distress tolerance skills |
| Health Education | Placebo comparator | Behavioral: Health Education7 didactic health education sessions |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- initiating buprenorphine treatment (which requires meeting current criteria for a DSM-IV diagnosis of opioid dependence)
- plan to remain on buprenorphine for at least three months
- age between 18 and 65 years
- if female of childbearing potential -- must be using adequate contraception (an intrauterine device, oral contraceptive, depot contraceptive, a barrier method "every time," or hysterectomy) as assessed by the study physician
- has at least two persons they regularly contact and can provide contact information for them
Key exclusion criteria (10 listed)
- current methadone maintenance treatment program participation
- medically necessary prescription opioid treatment (e.g., for chronic pain)
- current criteria for a DSM-IV diagnosis of substance dependence for sedative/hypnotic drugs, alcohol, stimulants, cocaine, inhalants, hallucinogens
- a diagnosis of organic brain disorder, bipolar disorder, schizophrenia, schizo-affective, schizophreniform, or paranoid disorder, or major depression (subjects who meet criteria for "substance-induced mood disorder," or dysthymia only will not be excluded)
- current suicidality on the Modified Scale for Suicidal Ideation
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 |
|---|---|---|
| Distress Tolerance7 individual sessions aimed at increasing distress tolerance skills | Behavioural | Distress Tolerance |
| Health Education7 individual sessions with didactic health education information | Behavioural | Health Education |
Primary outcome
the Client Satisfaction Questionnaire-8
Time frame: 4 months
assess patient satisfaction with services
buprenorphine treatment adherence
Time frame: 4 months
adherence to buprenorphine treatment, which includes opioid use and risk behaviors, will be assessed
1 secondary outcome
distress tolerance persistence
Time frame: 4 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 10 Sep 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Distress Tolerance and Health Education in people with Opioid Dependence, run by Butler 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 6 inclusion and 10 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 10 Sep 2015. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
the Client Satisfaction Questionnaire-8 (time frame: 4 months). The study lists 2 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 10 Sep 2015.