Substance Use Disorders
Conditions
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 (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.
Interventions
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.
BEHAVIORALRelaxation Therapy
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.
Sponsors
National Institute on Drug Abuse (NIDA)
University of Pittsburgh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants who discontinued BZDs at 4-month follow-up | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in quantity of BZD use | 4- and 6-months | Change in quantity of BZD used define by past-week BZD use by self-report in diazepam equivalent dose |
| Change in distress tolerance | 4- and 6-months | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Distress tolerance | 4- and 6-months | 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. Higher latency indicates greater distress tolerance. |
| BZD withdrawal symptoms | 4- and 6-months | 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. |
| Fear of anxiety symptoms | 4- and 6-months | 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. |
| Anxiety symptoms | 4- and 6-months | Anxiety symptoms will be measured using the Beck Anxiety Inventory (BAI), a 21-item self report inventory for measuring severity of anxiety. The items probe about common symptoms of anxiety that the participant may have experienced in the past week, including numbness, tingling, sweating, and fear. Each item is scored on a scale value of 0 (not at all) to 3 (severely). Higher total scores indicate more severe anxiety symptoms. The standardized cutoffs are: 0-7: minimal anxiety, 8-15: mild anxiety, 16-25: moderate anxiety, and 26-63: severe anxiety. |
| Depressive symptoms | 4- and 6-months | Depressive symptoms will be measured using the Beck Depression Inventory-II, a 21-item self report inventory measuring the severity of depression. The items probe on common symptoms of depression including hopelessness, irritability, guilt, weight-loss, fatigue, or lack of interest in daily activities. Higher total scores indicate more severe depressive symptoms. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe. |
| Inflexibility or experiential avoidance | 4- and 6-months | 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. |
Countries
United States
Outcome results
None listed