Substance Use DisordersDT-BDNCT05250570
Distress Tolerance for Benzodiazepine Discontinuation
A study testing Distress Tolerance - Benzodiazepine Discontinuation (DT-BD) and Relaxation Therapy in people with Substance Use Disorders, run by University of Pittsburgh at 3 sites 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 (OAT) who currently use benzodiazepines versus a Relaxation Therapy (RT) control condition. 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 Relaxation Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 3 sitesUnited States
- Study dates
- 17 Jun 2022to 9 Dec 2022
- 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
- Age 18 or older
- Receiving OAT (methadone or buprenorphine) for at least 2 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
- Capacity to provide informed consent
Who cannot join
- Pregnant, confirmed by urine pregnancy test
- Cognitive impairment, as indicated by Montreal Cognitive Assessment (MoCA): must score at least 26 on the MoCA with a one-point adjustment for individuals with formal education of 12 years or fewer
- Any past month illicit opioid determined by self-report or urine drug test; illicit defined as non-medical use
- 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
3 sites in 1 country.
United States3 sites
Center for Psychiatric and Chemical Dependency Services (CPCDS)
Pittsburgh, Pennsylvania, 15213
Internal Medicine Recovery Engagement Program (REP)
Pittsburgh, Pennsylvania, 15219
Narcotic Addiction Treatment Program (NATP)
Wilkinsburg, Pennsylvania, 15221
About this study
Official title: Distress Tolerance vs. Relaxation Therapy for Benzodiazepine Discontinuation in Patients Receiving Opioid Agonist Therapy
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 (OAT) who currently use benzodiazepines versus a Relaxation Therapy (RT) control condition. The DT-BD intervention is an adjunctive psychosocial intervention in people seeking to discontinue (BZD) use.
Read the detailed description
This study pilot tests a 13-week distress tolerance-based psychosocial intervention paired with a benzodiazepine taper comparing it to a relaxation therapy control condition 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 13 weeks with 5 weekly therapy sessions prior to 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 at baseline, then weekly for 13 weeks.
- Conditions
- Substance Use Disorders
- Being tested
- Distress Tolerance - Benzodiazepine Discontinuation (DT-BD), Relaxation Therapy
- 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
This psychosocial treatment intervention uses a combination of interoceptive exposure therapy and elements of acceptance and commitment therapy (ACT) to assist individuals in tolerating benzodiazepine withdrawal symptoms and teaching skills to prevent relapse to benzodiazepine use. It will also provide psychoeducation about benzodiazepine use in OAT. Both intervention and control arms will receive identical benzodiazepine discontinuation taper protocols.
Relaxation TherapyBehavioural
The relaxation therapy control condition involves psychoeducation about benzodiazepine use in OAT and progressive muscle-relaxation training. Both intervention and control arms will receive identical benzodiazepine discontinuation taper protocols.
| Study group | Role | What they receive |
|---|---|---|
| Distress Tolerance - Benzodiazepine Discontinuation (DT-BD) | Experimental | 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. Receives: Behavioral: Distress Tolerance - Benzodiazepine Discontinuation (DT-BD) |
| Relaxation Therapy | Active comparator | The relaxation therapy control condition involves psychoeducation about benzodiazepine use in OAT and progressive muscle-relaxation training. Receives: Behavioral: Relaxation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who discontinued BZDs at 4-month follow-up
Number of participants with BZD discontinuation defined by no BZD use by self-report during the month prior to 4-month follow-up corroborated by urine testing.
Measured: 4-months
Number of participants who discontinued BZDs at 6-month follow-up
Number of participants with BZD discontinuation defined by no BZD use by self-report during the month prior to 6-month follow-up corroborated by urine testing.
Measured: 6-months
Secondary outcomes (2)
Change in quantity of BZD use
Change in quantity of BZD used define by past-week BZD use by self-report in diazepam equivalent dose
Measured: 4- and 6-months
Change in distress tolerance
Change in distress tolerance defined by change in Distress Intolerance Index (DII) score from baseline to 6 month follow-up. The DII is a 10-item instrument. Items are rated from 0 (very little) to 4 (very much) and are summed for a total score (range 0-40), with higher scores indicating worse ability to tolerate distress.
Measured: 4- and 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2022
- Study start17 Jun 2022
- Primary completion9 Dec 2022
- Study completion9 Dec 2022
Why it stopped: Difficulty with recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance Use DisordersStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Tae Woo Park, University of Pittsburgh
- Investigators
- Tae Woo Park, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05250570
- Sponsor's protocol ID
- STUDY21110078
- Other IDs
- 7K23DA044321-06
- Acronym
- DT-BD
- Status last verified
- Jan 2023
- First submitted
- 31 Jan 2022
- Last updated
- 30 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Distress Tolerance vs. Relaxation Therapy for Benzodiazepine Discontinuation in Patients Receiving Opioid Agonist Therapy
- ClinicalTrials.gov ID
- NCT05250570
- Acronym / sponsor ID
- DT-BD / STUDY21110078
- Conditions
- Substance Use Disorders
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty with recruitment
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 17 Jun 2022 (actual)
- Primary completion
- 9 Dec 2022 (actual)
- Study completion
- 9 Dec 2022 (actual)
- First posted
- 22 Feb 2022 (actual)
- 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 proposed study is a clinical trial, designed to pilot test a Distress Tolerance-Benzodiazepine Discontinuation (DT-BD) intervention for patients on opioid agonist therapy (OAT) who currently use benzodiazepines versus a Relaxation Therapy (RT) control condition. The DT-BD intervention is an adjunctive psychosocial intervention in people seeking to discontinue (BZD) use.
Detailed description
This study pilot tests a 13-week distress tolerance-based psychosocial intervention paired with a benzodiazepine taper comparing it to a relaxation therapy control condition 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 13 weeks with 5 weekly therapy sessions prior to 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 at baseline, then weekly for 13 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Distress Tolerance - Benzodiazepine Discontinuation (DT-BD) | Experimental | Behavioral: Distress Tolerance - Benzodiazepine Discontinuation (DT-BD)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. |
| Relaxation Therapy | Active comparator | Behavioral: Relaxation TherapyThe relaxation therapy control condition involves psychoeducation about benzodiazepine use in OAT and progressive muscle-relaxation training. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18 or older
- Receiving OAT (methadone or buprenorphine) for at least 2 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 Montreal Cognitive Assessment (MoCA): must score at least 26 on the MoCA with a one-point adjustment for individuals with formal education of 12 years or fewer
- Any past month illicit opioid determined by self-report or urine drug test; illicit defined as non-medical use
- 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)This psychosocial treatment intervention uses a combination of interoceptive exposure therapy and elements of acceptance and commitment therapy (ACT) to assist individuals in tolerating benzodiazepine withdrawal symptoms and teaching skills to prevent relapse to benzodiazepine use. It will also provide psychoeducation about benzodiazepine use in OAT. Both intervention and control arms will receive identical benzodiazepine discontinuation taper protocols. | Behavioural | Distress Tolerance - Benzodiazepine Discontinuation (DT-BD) |
| Relaxation TherapyThe relaxation therapy control condition involves psychoeducation about benzodiazepine use in OAT and progressive muscle-relaxation training. Both intervention and control arms will receive identical benzodiazepine discontinuation taper protocols. | Behavioural | Relaxation Therapy |
Primary outcome
Number of participants who discontinued BZDs at 4-month follow-up
Time frame: 4-months
Number of participants with BZD discontinuation defined by no BZD use by self-report during the month prior to 4-month follow-up corroborated by urine testing.
Number of participants who discontinued BZDs at 6-month follow-up
Time frame: 6-months
Number of participants with BZD discontinuation defined by no BZD use by self-report during the month prior to 6-month follow-up corroborated by urine testing.
2 secondary outcomes
Change in quantity of BZD use
Time frame: 4- and 6-months
Change in distress tolerance
Time frame: 4- and 6-months
Results and safety
The study was stopped early (reason given: Difficulty with recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2023.
- 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
University of Pittsburgh
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Distress Tolerance - Benzodiazepine Discontinuation (DT-BD) and Relaxation Therapy in people with Substance Use Disorders, run by University of Pittsburgh at 3 sites 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 7 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: stopped early, as of the sponsor's last update on 30 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 was stopped early (reason given: Difficulty with recruitment). Results are not available in the source record.
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?
Number of participants who discontinued BZDs at 4-month follow-up (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 30 Jan 2023.