Substance Use Disorders
Conditions
Keywords
Opioid agonist therapy, Benzodiazepine, Distress tolerance, Distress Tolerance - Benzodiazepine Discontinuation (DT-BD), Relaxation Therapy (RT)
Brief 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. 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.
Interventions
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).
DRUGBZD discontinuation protocol
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.
Sponsors
National Institute on Drug Abuse (NIDA)
Boston Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age 18 or older 2. Receiving OAT (methadone or buprenorphine) confirmed by toxicology testing for at least 90 days and on a steady dose for 2 consecutive weeks 3. 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 4. Provides permission to contact current BZD prescriber if being prescribed BZDs 5. Speaks English 6. Wants to discontinue BZD use
Exclusion criteria
1. Pregnant, confirmed by urine pregnancy test 2. Cognitive impairment, as indicated by a score of \< 23 on the Mini Mental Status Exam 3. Any past month illicit opioid, barbiturate, z-drug, cocaine, unprescribed amphetamine, or synthetic cannabinoid use determined by self-report or urine drug test 4. Receiving ongoing psychosocial treatment for BZD use disorder 5. Uncontrolled seizure disorder (i.e. seizure in prior 90 days), or past BZD withdrawal seizure 6. Current suicidality or homicidality 7. Current psychotic symptoms
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participant Acceptability of the Interventions | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Illicit Drug Use Based on Urine Drug Tests | 13 weeks | 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. |
| Completion of Intervention | 13 weeks | 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. |
| Alcohol Use Based on Self-report | 13 weeks | 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. |
| BZD Withdrawal Symptoms | 13 weeks | 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. |
| Anxiety Symptoms | 13 weeks | 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. |
| Depressive Symptoms | 13 weeks | 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. |
| BZD Use Based on Self-report | 13 weeks | 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. |
| Inability to Tolerate Negative States | 13 weeks | 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. |
| Inflexibility or Experiential Avoidance | 13 weeks | 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. |
| Fear of Anxiety Symptoms | 13 weeks | 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. |
| Number of Participants Assessed for Distress Tolerance | 13 weeks | 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. |
| Number of Participants Assessed for Motivations to Use BZD | 13 weeks | 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. |
| Sleep Quality | 13 weeks | 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. |
| Alcohol Use Based on Urine Drug Tests | 13 weeks | Urine drug tests will include a ethyl glucuronide (EtG) test to detect the presence in the urine of ethyl glucuronide. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Distress Tolerance - Benzodiazepine Discontinuation (DT-BD) This is a pilot clinical trial of the DT-BD intervention. The study population will consist of outpatients receiving OAT for opioid use disorder who are also using BZDs regularly. All participants will receive the same BZD discontinuation protocol.
DT-BD is paired with a benzodiazepine taper. The aim of the psychosocial intervention is to improve individuals' ability to tolerate distress in order to assist BZD discontinuation in patients treated with OAT. There will be 5 sessions between therapist and participant prior to the start of the BZD taper. The taper occurs over 9 weeks and involves weekly meetings with a BZD prescriber during which a gradual BZD dose reduction will take place.
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. | 4 |
| Total | 4 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 3 |
Baseline characteristics
| Characteristic | Distress Tolerance - Benzodiazepine Discontinuation (DT-BD) |
|---|---|
| Age, Continuous | 41.2 years STANDARD_DEVIATION 14.9 |
| Breath holding exercise (in seconds) | 54.5 seconds STANDARD_DEVIATION 39.5 |
| Currently prescribed BZD No | 1 Participants |
| Currently prescribed BZD Yes | 3 Participants |
| Distress Intolerance Index | 16 seconds STANDARD_DEVIATION 8 |
| Do you have children No | 2 Participants |
| Do you have children Yes | 2 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Ever been prescribed a BZD by a professional No | 0 Participants |
| Ever been prescribed a BZD by a professional Yes | 4 Participants |
| Ever used BZD without a prescription No | 2 Participants |
| Ever used BZD without a prescription Yes | 2 Participants |
| Ever used nonmedical BZD at least 3 times a week N/A | 2 Participants |
| Ever used nonmedical BZD at least 3 times a week No | 1 Participants |
| Ever used nonmedical BZD at least 3 times a week Yes | 1 Participants |
| First source of nonmedical BZD Given by acquaintance | 1 Participants |
| First source of nonmedical BZD Given by family member | 1 Participants |
| First source of nonmedical BZD Not applicable | 2 Participants |
| Frequency of using nonmedical benzodiazepine to relax N/A | 3 Participants |
| Frequency of using nonmedical benzodiazepine to relax often | 1 Participants |
| Highest level of education 8-12th grade, no diploma | 0 Participants |
| Highest level of education 8th grade or less | 0 Participants |
| Highest level of education Associate Degree | 0 Participants |
| Highest level of education Bachelor's Degree | 0 Participants |
| Highest level of education Completed a vocational, trade, or business school program | 1 Participants |
| Highest level of education Doctorate Degree | 0 Participants |
| Highest level of education High school graduate or GED complete | 3 Participants |
| Highest level of education Master's Degree | 0 Participants |
| Highest level of education Some college, no degree | 0 Participants |
| How helpful were the information and skill from this session? A little helpful | 0 Participants |
| How helpful were the information and skill from this session? Extremely helpful | 3 Participants |
| How helpful were the information and skill from this session? not at all helfpful | 0 Participants |
| How helpful were the information and skill from this session? Somewhat helpful | 0 Participants |
| How helpful were the information and skill from this session? Very helpful | 1 Participants |
| How well did you understand the information and skills presented in the session? did not undrestand | 0 Participants |
| How well did you understand the information and skills presented in the session? Understood a little | 0 Participants |
| How well did you understand the information and skills presented in the session? Understood extremely well | 3 Participants |
| How well did you understand the information and skills presented in the session? Understood some | 0 Participants |
| How well did you understand the information and skills presented in the session? Understood very well | 1 Participants |
| Marital Status Divorced | 1 Participants |
| Marital Status Married | 0 Participants |
| Marital Status Never married | 2 Participants |
| Marital Status Not married, but living with a partner | 1 Participants |
| Pittsburgh Sleep Quality Index rate sleep quality Fairly bad | 0 Participants |
| Pittsburgh Sleep Quality Index rate sleep quality Fairly good | 1 Participants |
| Pittsburgh Sleep Quality Index rate sleep quality Very bad | 2 Participants |
| Pittsburgh Sleep Quality Index rate sleep quality Very Good | 1 Participants |
| Psychiatric diagnostic interview Alcohol use disorder +Bipolar I Disorder (past): depressed | 1 Participants |
| Psychiatric diagnostic interview Major Depressive Disorder | 1 Participants |
| Psychiatric diagnostic interview Obsessive Compulsive Disorder + Major depressive disorder | 1 Participants |
| Psychiatric diagnostic interview Panic Disorder Current + substance use disorder | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 3 Participants |
| Reason for being prescribed BZD Anxiety | 3 Participants |
| Reason for being prescribed BZD Depression | 0 Participants |
| Reason for being prescribed BZD Other Psychiatric Disorder | 1 Participants |
| Reason for being prescribed BZD Pain | 0 Participants |
| Reason for being prescribed BZD Sleep | 0 Participants |
| Reason for using nonmedical BZD Help with panic attack | 1 Participants |
| Reason for using nonmedical BZD Not applicable | 2 Participants |
| Reason for using nonmedical BZD To get high/for eurphoria | 1 Participants |
| Region of Enrollment United States | 4 participants |
| Self-report on drug use in the past 30 days Did not use drug | 4 Participants |
| Self-report on drug use in the past 30 days Used drug | 0 Participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 2 Participants |
| Sexual orientation Bisexual | 1 Participants |
| Sexual orientation Heterosexual | 3 Participants |
| Sexual orientation Homosexual | 0 Participants |
| Sexual orientation Other | 0 Participants |
| Urine drug screen Negative | 4 Participants |
| Urine drug screen Positive | 0 Participants |
| Used nonmedical BZD in the past 12 months N/A | 2 Participants |
| Used nonmedical BZD in the past 12 months No | 1 Participants |
| Used nonmedical BZD in the past 12 months Yes | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 4 |
| other Total, other adverse events | 0 / 4 |
| serious Total, serious adverse events | 0 / 4 |
Outcome results
Primary
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
Population: 3 out of the 4 participants were lost to follow-up prior to the collection of this primary outcome measure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Distress Tolerance - Benzodiazepine Discontinuation (DT-BD) | Number of Participants Who Rates the Intervention as Feasible | 1 Participants |
Primary
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
Population: 3 out of the 4 participants were lost to follow-up prior to the collection of this primary outcome measure
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Distress Tolerance - Benzodiazepine Discontinuation (DT-BD) | Participant Acceptability of the Interventions | Thought that the program was acceptable and feasible | 1 Participants |
| Distress Tolerance - Benzodiazepine Discontinuation (DT-BD) | Participant Acceptability of the Interventions | Thought that the program was not acceptable and feasible | 0 Participants |
Secondary
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
Population: 3 out of the 4 participants were lost to follow-up prior to the collection of this primary outcome measure
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Distress Tolerance - Benzodiazepine Discontinuation (DT-BD) | Alcohol Use Based on Self-report | Used alcohol | 0 Participants |
| Distress Tolerance - Benzodiazepine Discontinuation (DT-BD) | Alcohol Use Based on Self-report | Did not use alcohol | 1 Participants |
Secondary
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
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Distress Tolerance - Benzodiazepine Discontinuation (DT-BD) | Alcohol Use Based on Urine Drug Tests | Did not use alcohol | 1 Participants |
| Distress Tolerance - Benzodiazepine Discontinuation (DT-BD) | Alcohol Use Based on Urine Drug Tests | Used alcohol | 0 Participants |
Secondary
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
Population: 3 out of the 4 participants were lost to follow-up prior to the collection of this primary outcome measure
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Distress Tolerance - Benzodiazepine Discontinuation (DT-BD) | Anxiety Symptoms | no severity and impairment associated with any anxiety disorder | 1 Participants |
| Distress Tolerance - Benzodiazepine Discontinuation (DT-BD) | Anxiety Symptoms | severity and impairment associated with any anxiety disorder | 0 Participants |
Secondary
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
Population: 3 out of the 4 participants were lost to follow-up prior to the collection of this primary outcome measure
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Distress Tolerance - Benzodiazepine Discontinuation (DT-BD) | BZD Use Based on Self-report | Used Drugs | 0 Participants |
| Distress Tolerance - Benzodiazepine Discontinuation (DT-BD) | BZD Use Based on Self-report | Did not use drugs | 1 Participants |
Secondary
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
Population: 3 out of the 4 participants were lost to follow-up prior to the collection of this primary outcome measure
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Distress Tolerance - Benzodiazepine Discontinuation (DT-BD) | BZD Withdrawal Symptoms | mild withdrawal (total score 1-20) | 1 Participants |
| Distress Tolerance - Benzodiazepine Discontinuation (DT-BD) | BZD Withdrawal Symptoms | severe withdrawal (Total score 21-40) | 0 Participants |
| Distress Tolerance - Benzodiazepine Discontinuation (DT-BD) | BZD Withdrawal Symptoms | very severe withdrawal (Total score 41-80) | 0 Participants |
Secondary
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
Population: 3 out of the 4 participants were lost to follow-up prior to the collection of this primary outcome measure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Distress Tolerance - Benzodiazepine Discontinuation (DT-BD) | Completion of Intervention | 1 Participants |
Secondary
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
Population: 3 out of the 4 participants were lost to follow-up prior to the collection of this primary outcome measure
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Distress Tolerance - Benzodiazepine Discontinuation (DT-BD) | Depressive Symptoms | depression present | 0 Participants |
| Distress Tolerance - Benzodiazepine Discontinuation (DT-BD) | Depressive Symptoms | no depression | 1 Participants |
Secondary
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
Population: 3 out of the 4 participants were lost to follow-up prior to the collection of this primary outcome measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Distress Tolerance - Benzodiazepine Discontinuation (DT-BD) | Fear of Anxiety Symptoms | 10 score on a scale | Standard Deviation 0 |
Secondary
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
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Distress Tolerance - Benzodiazepine Discontinuation (DT-BD) | Illicit Drug Use Based on Urine Drug Tests | Used drugs | 0 Participants |
| Distress Tolerance - Benzodiazepine Discontinuation (DT-BD) | Illicit Drug Use Based on Urine Drug Tests | Did not use drugs | 1 Participants |
Secondary
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
Population: 3 out of the 4 participants were lost to follow-up prior to the collection of this primary outcome measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Distress Tolerance - Benzodiazepine Discontinuation (DT-BD) | Inability to Tolerate Negative States | 3 score on a scale | Standard Deviation 0 |
Secondary
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
Population: 3 out of the 4 participants were lost to follow-up prior to the collection of this primary outcome measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Distress Tolerance - Benzodiazepine Discontinuation (DT-BD) | Inflexibility or Experiential Avoidance | 3 score on a scale | Standard Deviation 0 |
Secondary
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
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Distress Tolerance - Benzodiazepine Discontinuation (DT-BD) | Number of Participants Assessed for Distress Tolerance | Mirror Tracing Complete | 1 Participants |
| Distress Tolerance - Benzodiazepine Discontinuation (DT-BD) | Number of Participants Assessed for Distress Tolerance | Mirror Tracing Incomplete | 0 Participants |
Secondary
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
Population: 3 out of the 4 participants were lost to follow-up prior to the collection of this primary outcome measure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Distress Tolerance - Benzodiazepine Discontinuation (DT-BD) | Number of Participants Assessed for Motivations to Use BZD | 1 Participants |
Secondary
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
Population: 3 out of the 4 participants were lost to follow-up prior to the collection of this primary outcome measure
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Distress Tolerance - Benzodiazepine Discontinuation (DT-BD) | Sleep Quality | total score below 5 | 0 Participants |
| Distress Tolerance - Benzodiazepine Discontinuation (DT-BD) | Sleep Quality | total score above 5 | 1 Participants |