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Benzodiazepine Discontinuation in Opioid Agonist Therapy
Phase 2 trial testing Distress Tolerance - Benzodiazepine Discontinuation (DT-BD) in Substance Use Disorders in 4 participants. Completed in 8 July 2021.
| Lead sponsor | Boston Medical Center |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 4 |
| Start date | 18 March 2021 |
| Primary completion | 8 July 2021 |
| Estimated completion | 8 July 2021 |
| Sites | 1 location across United States |
Boston Medical Center
18 and older, any sex, with Substance Use Disorders. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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.
| Group | Value | 95% CI |
|---|---|---|
| Distress Tolerance - Benzodiazepine Discontinuation (DT-BD) | 1 | |
| Distress Tolerance - Benzodiazepine Discontinuation (DT-BD) | 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.
| Group | Value | 95% CI |
|---|---|---|
| Distress Tolerance - Benzodiazepine Discontinuation (DT-BD) | 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.
| Group | Value | 95% CI |
|---|---|---|
| Distress Tolerance - Benzodiazepine Discontinuation (DT-BD) | 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.
| Group | Value | 95% CI |
|---|---|---|
| Distress Tolerance - Benzodiazepine Discontinuation (DT-BD) | 0 | |
| Distress Tolerance - Benzodiazepine Discontinuation (DT-BD) | 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.
| Group | Value | 95% CI |
|---|---|---|
| Distress Tolerance - Benzodiazepine Discontinuation (DT-BD) | 0 | |
| Distress Tolerance - Benzodiazepine Discontinuation (DT-BD) | 1 |
Urine drug tests will include a ethyl glucuronide (EtG) test to detect the presence in the urine of ethyl glucuronide.
| Group | Value | 95% CI |
|---|---|---|
| Distress Tolerance - Benzodiazepine Discontinuation (DT-BD) | 1 | |
| Distress Tolerance - Benzodiazepine Discontinuation (DT-BD) | 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.
| Group | Value | 95% CI |
|---|---|---|
| Distress Tolerance - Benzodiazepine Discontinuation (DT-BD) | 0 | |
| Distress Tolerance - Benzodiazepine Discontinuation (DT-BD) | 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.
| Group | Value | 95% CI |
|---|---|---|
| Distress Tolerance - Benzodiazepine Discontinuation (DT-BD) | 1 | |
| Distress Tolerance - Benzodiazepine Discontinuation (DT-BD) | 0 | |
| Distress Tolerance - Benzodiazepine Discontinuation (DT-BD) | 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.
| Group | Value | 95% CI |
|---|---|---|
| Distress Tolerance - Benzodiazepine Discontinuation (DT-BD) | 1 | |
| Distress Tolerance - Benzodiazepine Discontinuation (DT-BD) | 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.
| Group | Value | 95% CI |
|---|---|---|
| Distress Tolerance - Benzodiazepine Discontinuation (DT-BD) | 1 | |
| Distress Tolerance - Benzodiazepine Discontinuation (DT-BD) | 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.
| Group | Value | 95% CI |
|---|---|---|
| Distress Tolerance - Benzodiazepine Discontinuation (DT-BD) | 1 | |
| Distress Tolerance - Benzodiazepine Discontinuation (DT-BD) | 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.
| Group | Value | 95% CI |
|---|---|---|
| Distress Tolerance - Benzodiazepine Discontinuation (DT-BD) | 3 | ± 0 |
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.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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