Distress Tolerance for Benzodiazepine Discontinuation

Substance Use Disorders Clinical Trial

— DT-BD  

Official title:

Distress Tolerance vs. Relaxation Therapy for Benzodiazepine Discontinuation in Patients Receiving Opioid Agonist Therapy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05250570
• Other study ID #: STUDY21110078
• Secondary ID: 7K23DA044321-06
• Status: Terminated
• Phase: N/A
• Start date: June 17, 2022
• Est. completion date: December 9, 2022

Study information

• Verified date: January 2023
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. The DT-BD intervention is an adjunctive psychosocial intervention in people seeking to discontinue (BZD) use.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: December 9, 2022
• Est. primary completion date: December 9, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Substance Use Disorders
• Substance-Related Disorders

Intervention

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) 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 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.

Locations

Country	Name	City	State
United States	Center for Psychiatric and Chemical Dependency Services (CPCDS)	Pittsburgh	Pennsylvania
United States	Internal Medicine Recovery Engagement Program (REP)	Pittsburgh	Pennsylvania
United States	Narcotic Addiction Treatment Program (NATP)	Wilkinsburg	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	4- and 6-months
Other	Anxiety symptoms	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.	4- and 6-months
Other	Depressive symptoms	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.	4- and 6-months
Other	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.	4- and 6-months
Other	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. Higher latency indicates greater distress tolerance.	4- and 6-months
Other	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.	4- and 6-months
Primary	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.	4-months
Primary	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.	6-months
Secondary	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	4- and 6-months
Secondary	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.	4- and 6-months