Substance Use DisordersPhase 2BZD-OATNCT04109118
Benzodiazepine Discontinuation in Opioid Agonist Therapy
A Phase 2 study testing Distress Tolerance - Benzodiazepine Discontinuation (DT-BD) and BZD discontinuation protocol in people with Substance Use Disorders, run by Boston Medical Center at 1 site in United States.
Trial summary
The proposed study is a clinical trial, designed to pilot test a Distress Tolerance-Benzodiazepine Discontinuation (DT-BD) intervention for patients on opioid agonist therapy who currently use benzodiazepines. The DT-BD intervention is an adjunctive psychosocial intervention in people seeking to discontinue (BZD) use. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Substance Use Disorders
- What is being tested?
- Distress Tolerance - Benzodiazepine Discontinuation (DT-BD) and BZD discontinuation protocol
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Mar 2021to 8 Jul 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Age 18 or older
- Receiving OAT (methadone or buprenorphine) confirmed by toxicology testing for at least 90 days and on a steady dose for 2 consecutive weeks
- Regular BZD use defined by BZD use 3 or more times per week in past month by self-report and positive urine screen at time of recruitment
- Provides permission to contact current BZD prescriber if being prescribed BZDs
- Speaks English
- Wants to discontinue BZD use
Who cannot join
- Pregnant, confirmed by urine pregnancy test
- Cognitive impairment, as indicated by a score of < 23 on the Mini Mental Status Exam
- Any past month illicit opioid, barbiturate, z-drug, cocaine, unprescribed amphetamine, or synthetic cannabinoid use determined by self-report or urine drug test
- Receiving ongoing psychosocial treatment for BZD use disorder
- Uncontrolled seizure disorder (i.e. seizure in prior 90 days), or past BZD withdrawal seizure
- Current suicidality or homicidality
- Current psychotic symptoms
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Distress Tolerance and Benzodiazepine Discontinuation in Opioid Agonist Therapy, Phase 2
The proposed study is a clinical trial, designed to pilot test a Distress Tolerance-Benzodiazepine Discontinuation (DT-BD) intervention for patients on opioid agonist therapy who currently use benzodiazepines. The DT-BD intervention is an adjunctive psychosocial intervention in people seeking to discontinue (BZD) use. The goal of the study is to assess the applicability and feasibility of this intervention through treatment retention and qualitative interviews with four participants who are receiving opioid agonist treatment and who regularly use BZDs.
Read the detailed description
This study pilots a 13-week psychosocial intervention paired with a benzodiazepine taper with the aim of assisting individuals receiving OAT discontinue benzodiazepine use. All participants will receive the same benzodiazepine (BZD) discontinuation protocol. The Distress Tolerance-Benzodiazepine Discontinuation (DT-BD) intervention consists of 14 study visits: the first visit consists of the baseline assessment and the first therapy visits, 4 subsequent weekly therapy visits, then a 9-week BZD taper. Some participants may be prescribed non-benzodiazepine medications to treat the underlying conditions for which they were using BZDs [e.g. selective serotonin reuptake inhibitors (SSRI) for anxiety or hypnotics for insomnia]. Data collection will occur starting at the baseline assessment.
- Conditions
- Substance Use Disorders
- Being tested
- Distress Tolerance - Benzodiazepine Discontinuation (DT-BD), BZD discontinuation protocol
- Keywords
- Opioid agonist therapy, Benzodiazepine, Distress tolerance, Distress Tolerance - Benzodiazepine Discontinuation (DT-BD), Relaxation Therapy (RT)
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Distress Tolerance - Benzodiazepine Discontinuation (DT-BD)Behavioural
Distress Tolerance - Benzodiazepine Discontinuation (DT-BD) is a psychosocial intervention. It is paired with a benzodiazepine taper. The aim of the psychosocial intervention is to improve individuals' ability to tolerate distress in order to assist benzodiazepine discontinuation in patients treated with OAT. There will be 5 sessions between therapist and participant prior to the start of the benzodiazepine taper. The taper for both the intervention and control conditions occurs over 9 weeks and involves weekly meetings with a benzodiazepine prescriber during which a gradual benzodiazepine dose reduction will take place. The DT-BD intervention combines elements of existing psychosocial interventions. Specifically, interoceptive exposure techniques will be paired with elements of acceptance and commitment therapy (ACT) and relapse prevention (RP).
BZD discontinuation protocolDrug
Also called Benzodiazepine
All participants will undergo BZD discontinuation. Once the starting BZD dose is determined by prescription monitoring and/or self-report, we will maintain participants on this dose until the start of the BZD taper. Participants will see a study physician weekly to receive their BZD medication for the week until the taper is completed. BZD discontinuation in this study will consist of a gradual BZD taper in dose over 9 weeks. The taper will be flexible in that the study physician will utilize clinical judgement to lengthen the taper if necessary, depending on the severity of the participant's withdrawal symptoms. Anchor points will be set (33% reduction in dose after 2 weeks, 50% mid-treatment, 100% by week 8) to emphasize the time-limited nature of the taper.
| Study group | Role | What they receive |
|---|---|---|
| Distress Tolerance - Benzodiazepine Discontinuation (DT-BD) | Other | This psychosocial treatment intervention uses a combination of interoceptive exposure therapy and elements of acceptance and commitment therapy (ACT) and psychoeducation about benzodiazepine use in OAT.
Of note, this is a pilot trial for feasibility and acceptability. There is no randomization and we are not comparing arms. Receives: Behavioral: Distress Tolerance - Benzodiazepine Discontinuation (DT-BD); Drug: BZD discontinuation protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant Acceptability of the Interventions
Number of participants who rated the intervention as acceptable, this was assessed by conducting an in-depth exit interview with the participant once they complete the entire 13-week study.
Measured: 13 weeks
Number of Participants Who Rates the Intervention as Feasible
Feasibility of intervention will be measured through the number of participants recruited and enrolled in the study, number of participants who started the BZD taper, and completed assessment tools.
Measured: 13 weeks
Secondary outcomes (14)
Completion of Intervention
Completion of intervention will be measured through participant attendance of weekly sessions. Participants must attend all 13 sessions (Baseline, 3 weekly therapy sessions prior to taper, and 8 week BZD taper urine/drug screens). Participants, who miss a study visit, will be considered discontinued from the study if study staff are unable to get in contact with them 7 days after their missed study visit.
Measured: 13 weeks
BZD Use Based on Self-report
Timeline follow-back will be measured using the 30-day Timeline Followback (TLFB), adapted for BZD use. The Timeline Followback (TLFB) is a clinical and research method to obtain quantitative estimates of drug or alcohol use, and change over time. Participants will be asked to retrospectively estimate their BZD use 7 days prior to study visit. We will also monitor BZD use on a daily basis with a mobile phone application.
Measured: 13 weeks
Illicit Drug Use Based on Urine Drug Tests
Illicit drug use urine tests will screen for amphetamines, benzodiazepines, opiates, oxycodone, fentanyl, cocaine, barbiturates, and methadone. Plus: liquid chromatography-mass spectrometry for clonazepam and lorazepam, and fentanyl if fentanyl test (immunoassay) is positive.
Measured: 13 weeks
Alcohol Use Based on Urine Drug Tests
Urine drug tests will include a ethyl glucuronide (EtG) test to detect the presence in the urine of ethyl glucuronide.
Measured: 13 weeks
Alcohol Use Based on Self-report
Timeline follow-back will be measured using the 30-day Timeline Followback (TLFB). The Timeline Followback (TLFB) is a clinical and research method to obtain quantitative estimates of drug or alcohol use, and change over time. Participants will be asked to retrospectively estimate their alcohol use 7 days prior to study visit. The alcohol adaption includes estimates of 1 standard drink in terms of beer, wine, and hard liquor. We will also monitor alcohol use on a daily basis with a mobile phone application.
Measured: 13 weeks
BZD Withdrawal Symptoms
BZD withdrawal symptoms will be measured using the Clinical Institute Withdrawal Assessment-Benzodiazepines (CIWA-B). The CIWA-B is a 20 item instrument, to assess severity of benzodiazepine withdrawal, including nausea and vomiting, anxiety, tremor, sweating, auditory disturbances, visual disturbances, tactile disturbances, headache, agitation, and clouding of sensorium. Scores range from 0 to 80, with 1-20 mild withdrawal, 21-40 moderate withdrawal, 41-60 severe withdrawal, and 61-80 very severe withdrawal.
Measured: 13 weeks
Anxiety Symptoms
The Overall Anxiety Severity and Impairment Scale (OASIS) is a 5-item self-report measure that can be used to assess severity and impairment associated with any anxiety disorder or multiple anxiety disorders.
Measured: 13 weeks
Depressive Symptoms
The Patient Health Questionnaire (PHQ)-9 is the major depressive disorder (MDD) module of the full PHQ.
It is used to diagnose depression and grade severity of symptoms in general medical and mental health settings.
Scores each of the 9 DSM criteria of MDD as "0" (not at all) to "3" (nearly every day), providing a 0-27 severity score.
Measured: 13 weeks
Sleep Quality
Sleep quality will be measured using the Pittsburgh Sleep Quality Index (PSQI), a 9 item self report instrument, designed to measure quality and patterns of sleep from very good to very bad. Sleep quality will also be measured on a daily basis with a mobile phone application. A global score of 5 or more indicates poor sleep quality; the higher the score, the worse the quality.
Measured: 13 weeks
Inability to Tolerate Negative States
The Distress Intolerance (DI) Index will be used to assess Inability to tolerate negative states.The index is a 10 item self-report measure designed to assess the inability to tolerate negative states. Items are rated from 0 (very little) to 4 (very much) and are summed for a total score, with higher scores indicating greater DI.
Measured: 13 weeks
Inflexibility or Experiential Avoidance
The Acceptance and Action Questionnaire-II will be used to measure inflexibility or experiential avoidance. It is a 7 item self-report measure of psychological inflexibility or experiential avoidance. Each of the 7 items can be rated on a scale of 1 (never true) to 7 (always true) so scores can range from 7 to 49. Higher scores equal greater levels of psychological inflexibility.
Measured: 13 weeks
Fear of Anxiety Symptoms
Fear of anxiety symptoms will be assessed by the Anxiety Sensitivity Index. It is a 16 item scale with each item rated on a five-point Likert scale ranging from 0 (very little) to 4 (very much). Scores can range from 0 to 64. Higher scores reflect greater fear of anxiety symptoms.
Measured: 13 weeks
Number of Participants Assessed for Distress Tolerance
Distress tolerance will be assessed with the computerized Mirror Tracing Persistence Task (MTPT-C). It is a computerized version of the original Mirror Tracing Persistence Task in which trace multiple progressively difficult polygons, with participants free to terminate at any point. Distress tolerance is measured by the latency in seconds to task termination.
Measured: 13 weeks
Number of Participants Assessed for Motivations to Use BZD
BZD motivations will be measured using the 12 item BZD Motivation Scale, a self report questionnaire. The questionnaire uses a 4 point Likert scale to assess participant motivations for using BZD, such as managing pain, insomnia, anxiety, and increase high of other illicit drugs.
Measured: 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2019
- Study start18 Mar 2021
- Primary completion8 Jul 2021
- Study completion8 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Substance Use DisordersStudies of the same condition, open and under way.
- More trials run by Boston Medical CenterThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Tae Woo Park, MD, Principal investigator, Boston Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04109118
- Sponsor's protocol ID
- H-38981
- Other IDs
- 1K23DA044321-01
- Acronym
- BZD-OAT
- Status last verified
- Jan 2022
- First submitted
- 25 Sep 2019
- Last updated
- 11 Feb 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Distress Tolerance and Benzodiazepine Discontinuation in Opioid Agonist Therapy, Phase 2
- ClinicalTrials.gov ID
- NCT04109118
- Acronym / sponsor ID
- BZD-OAT / H-38981
- Conditions
- Substance Use Disorders
- Keywords
- Opioid agonist therapy, Benzodiazepine, Distress tolerance, Distress Tolerance - Benzodiazepine Discontinuation (DT-BD), Relaxation Therapy (RT)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 18 Mar 2021 (actual)
- Primary completion
- 8 Jul 2021 (actual)
- Study completion
- 8 Jul 2021 (actual)
- First posted
- 30 Sep 2019 (actual)
- Results
- Posted 11 Feb 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The proposed study is a clinical trial, designed to pilot test a Distress Tolerance-Benzodiazepine Discontinuation (DT-BD) intervention for patients on opioid agonist therapy who currently use benzodiazepines. The DT-BD intervention is an adjunctive psychosocial intervention in people seeking to discontinue (BZD) use. The goal of the study is to assess the applicability and feasibility of this intervention through treatment retention and qualitative interviews with four participants who are receiving opioid agonist treatment and who regularly use BZDs.
Detailed description
This study pilots a 13-week psychosocial intervention paired with a benzodiazepine taper with the aim of assisting individuals receiving OAT discontinue benzodiazepine use. All participants will receive the same benzodiazepine (BZD) discontinuation protocol. The Distress Tolerance-Benzodiazepine Discontinuation (DT-BD) intervention consists of 14 study visits: the first visit consists of the baseline assessment and the first therapy visits, 4 subsequent weekly therapy visits, then a 9-week BZD taper. Some participants may be prescribed non-benzodiazepine medications to treat the underlying conditions for which they were using BZDs [e.g. selective serotonin reuptake inhibitors (SSRI) for anxiety or hypnotics for insomnia]. Data collection will occur starting at the baseline assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Distress Tolerance - Benzodiazepine Discontinuation (DT-BD) | Other | Behavioral: Distress Tolerance - Benzodiazepine Discontinuation (DT-BD), Drug: BZD discontinuation protocolThis psychosocial treatment intervention uses a combination of interoceptive exposure therapy and elements of acceptance and commitment therapy (ACT) and psychoeducation about benzodiazepine use in OAT. Of note, this is a pilot trial for feasibility and acceptability. There is no randomization and we are not comparing arms. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 or older
- Receiving OAT (methadone or buprenorphine) confirmed by toxicology testing for at least 90 days and on a steady dose for 2 consecutive weeks
- Regular BZD use defined by BZD use 3 or more times per week in past month by self-report and positive urine screen at time of recruitment
- Provides permission to contact current BZD prescriber if being prescribed BZDs
- Speaks English
Key exclusion criteria (7 listed)
- Pregnant, confirmed by urine pregnancy test
- Cognitive impairment, as indicated by a score of < 23 on the Mini Mental Status Exam
- Any past month illicit opioid, barbiturate, z-drug, cocaine, unprescribed amphetamine, or synthetic cannabinoid use determined by self-report or urine drug test
- Receiving ongoing psychosocial treatment for BZD use disorder
- Uncontrolled seizure disorder (i.e. seizure in prior 90 days), or past BZD withdrawal seizure
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 Tolerance - Benzodiazepine Discontinuation (DT-BD)Distress Tolerance - Benzodiazepine Discontinuation (DT-BD) is a psychosocial intervention. It is paired with a benzodiazepine taper. The aim of the psychosocial intervention is to improve individuals' ability to tolerate distress in order to assist benzodiazepine discontinuation in patients treated with OAT. There will be 5 sessions between therapist and participant prior to the start of the benzodiazepine taper. The taper for both the intervention and control conditions occurs over 9 weeks and involves weekly meetings with a benzodiazepine prescriber during which a gradual benzodiazepine dose reduction will take place. The DT-BD intervention combines elements of existing psychosocial interventions. Specifically, interoceptive exposure techniques will be paired with elements of acceptance and commitment therapy (ACT) and relapse prevention (RP). | Behavioural | Distress Tolerance - Benzodiazepine Discontinuation (DT-BD) |
| BZD discontinuation protocolAlso: BenzodiazepineAll participants will undergo BZD discontinuation. Once the starting BZD dose is determined by prescription monitoring and/or self-report, we will maintain participants on this dose until the start of the BZD taper. Participants will see a study physician weekly to receive their BZD medication for the week until the taper is completed. BZD discontinuation in this study will consist of a gradual BZD taper in dose over 9 weeks. The taper will be flexible in that the study physician will utilize clinical judgement to lengthen the taper if necessary, depending on the severity of the participant's withdrawal symptoms. Anchor points will be set (33% reduction in dose after 2 weeks, 50% mid-treatment, 100% by week 8) to emphasize the time-limited nature of the taper. | Drug | Distress Tolerance - Benzodiazepine Discontinuation (DT-BD) |
Primary outcome
Participant Acceptability of the Interventions
Time frame: 13 weeks
Number of participants who rated the intervention as acceptable, this was assessed by conducting an in-depth exit interview with the participant once they complete the entire 13-week study.
Number of Participants Who Rates the Intervention as Feasible
Time frame: 13 weeks
Feasibility of intervention will be measured through the number of participants recruited and enrolled in the study, number of participants who started the BZD taper, and completed assessment tools.
14 secondary outcomes
Completion of Intervention
Time frame: 13 weeks
BZD Use Based on Self-report
Time frame: 13 weeks
Illicit Drug Use Based on Urine Drug Tests
Time frame: 13 weeks
Alcohol Use Based on Urine Drug Tests
Time frame: 13 weeks
Alcohol Use Based on Self-report
Time frame: 13 weeks
BZD Withdrawal Symptoms
Time frame: 13 weeks
Anxiety Symptoms
Time frame: 13 weeks
Depressive Symptoms
Time frame: 13 weeks
Sleep Quality
Time frame: 13 weeks
Inability to Tolerate Negative States
Time frame: 13 weeks
Inflexibility or Experiential Avoidance
Time frame: 13 weeks
Fear of Anxiety Symptoms
Time frame: 13 weeks
Number of Participants Assessed for Distress Tolerance
Time frame: 13 weeks
Number of Participants Assessed for Motivations to Use BZD
Time frame: 13 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Tae Woo Park, MD principal investigator
Boston Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Distress Tolerance - Benzodiazepine Discontinuation (DT-BD) and BZD discontinuation protocol in people with Substance Use Disorders, run by Boston Medical Center 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 7 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 11 Feb 2022. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Feb 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Participant Acceptability of the Interventions (time frame: 13 weeks). 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 11 Feb 2022.