A Phase 2 interventional study of Distress Tolerance - Benzodiazepine Discontinuation (DT-BD) and BZD discontinuation protocol in Substance Use Disorders, sponsored by Boston Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-02-11.
Sponsored by Boston Medical Center · Phase 2, Interventional, and Treatment
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.
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.
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Exclusion Criteria:
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.
Behavioral: Distress Tolerance - Benzodiazepine Discontinuation (DT-BD) · Drug: BZD discontinuation protocol
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).
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.
Also known as: Benzodiazepine
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.
Time frame: 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.
Time frame: 13 weeks
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 13 weeks
Study recruitment began in March 2021. Potential participants identified by the study PI were given study information and PI obtained verbal consent from patients to have study staff call to invite them to participate over the phone. Interested potential participants were asked to complete a brief screening interview using the study screening script that involved asking questions based on the inclusion and exclusion criteria.
| Milestone | Distress Tolerance - Benzodiazepine Discontinuation (DT-BD) |
|---|---|
| Started | 4 |
| Completed | 1 |
| Not completed | 3 |
| Withdrew: Lost to follow-up | 3 |
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.
| Participants | Distress Tolerance - Benzodiazepine Discontinuation (DT-BD) |
|---|---|
| Thought that the program was acceptable and feasible | 1 |
| Thought that the program was not acceptable and feasible | 0 |
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.
| Participants | Distress Tolerance - Benzodiazepine Discontinuation (DT-BD) |
|---|---|
| Number of Participants Who Rates the Intervention as Feasible | 1 |
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.
| Participants | Distress Tolerance - Benzodiazepine Discontinuation (DT-BD) |
|---|---|
| Completion of Intervention | 1 |
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.
| Participants | Distress Tolerance - Benzodiazepine Discontinuation (DT-BD) |
|---|---|
| Used Drugs | 0 |
| Did not use drugs | 1 |
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.
| Participants | Distress Tolerance - Benzodiazepine Discontinuation (DT-BD) |
|---|---|
| Used drugs | 0 |
| Did not use drugs | 1 |
Urine drug tests will include a ethyl glucuronide (EtG) test to detect the presence in the urine of ethyl glucuronide.
| Participants | Distress Tolerance - Benzodiazepine Discontinuation (DT-BD) |
|---|---|
| Did not use alcohol | 1 |
| Used alcohol | 0 |
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.
| Participants | Distress Tolerance - Benzodiazepine Discontinuation (DT-BD) |
|---|---|
| Used alcohol | 0 |
| Did not use alcohol | 1 |
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.
| Participants | Distress Tolerance - Benzodiazepine Discontinuation (DT-BD) |
|---|---|
| mild withdrawal (total score 1-20) | 1 |
| severe withdrawal (Total score 21-40) | 0 |
| very severe withdrawal (Total score 41-80) | 0 |
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.
| Participants | Distress Tolerance - Benzodiazepine Discontinuation (DT-BD) |
|---|---|
| no severity and impairment associated with any anxiety disorder | 1 |
| severity and impairment associated with any anxiety disorder | 0 |
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.
| Participants | Distress Tolerance - Benzodiazepine Discontinuation (DT-BD) |
|---|---|
| no depression | 1 |
| depression present | 0 |
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.
| Participants | Distress Tolerance - Benzodiazepine Discontinuation (DT-BD) |
|---|---|
| total score above 5 | 1 |
| total score below 5 | 0 |
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.
| score on a scale | Distress Tolerance - Benzodiazepine Discontinuation (DT-BD) |
|---|---|
| Inability to Tolerate Negative States | 3 ± 0 |
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.
| score on a scale | Distress Tolerance - Benzodiazepine Discontinuation (DT-BD) |
|---|---|
| Inflexibility or Experiential Avoidance | 3 ± 0 |
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.
| score on a scale | Distress Tolerance - Benzodiazepine Discontinuation (DT-BD) |
|---|---|
| Fear of Anxiety Symptoms | 10 ± 0 |
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.
| Participants | Distress Tolerance - Benzodiazepine Discontinuation (DT-BD) |
|---|---|
| Mirror Tracing Complete | 1 |
| Mirror Tracing Incomplete | 0 |
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.
| Participants | Distress Tolerance - Benzodiazepine Discontinuation (DT-BD) |
|---|---|
| Number of Participants Assessed for Motivations to Use BZD | 1 |
Collected over 13 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Distress Tolerance - Benzodiazepine Discontinuation (DT-BD) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) |
| Age, Continuous(years) | Distress Tolerance - Benzodiazepine Discontinuation (DT-BD) |
|---|---|
| Mean | 41.2 ± 14.9 |
| Sex: Female, Male(Participants) | Distress Tolerance - Benzodiazepine Discontinuation (DT-BD) |
|---|---|
| Female | 2 |
| Male | 2 |
| Ethnicity (NIH/OMB)(Participants) | Distress Tolerance - Benzodiazepine Discontinuation (DT-BD) |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 4 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Distress Tolerance - Benzodiazepine Discontinuation (DT-BD) |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 1 |
| White | 3 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Distress Tolerance - Benzodiazepine Discontinuation (DT-BD) |
|---|---|
| United States | 4 |
| Self-report on drug use in the past 30 days(Participants) | Distress Tolerance - Benzodiazepine Discontinuation (DT-BD) |
|---|---|
| Used drug | 0 |
| Did not use drug | 4 |
| Urine drug screen(Participants) | Distress Tolerance - Benzodiazepine Discontinuation (DT-BD) |
|---|---|
| Positive | 0 |
| Negative | 4 |
| Psychiatric diagnostic interview(Participants) | Distress Tolerance - Benzodiazepine Discontinuation (DT-BD) |
|---|---|
| Panic Disorder Current + substance use disorder | 1 |
| Obsessive Compulsive Disorder + Major depressive disorder | 1 |
| Major Depressive Disorder | 1 |
| Alcohol use disorder +Bipolar I Disorder (past): depressed | 1 |
18 further baseline measures are reported on the registry.
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