Distress Tolerance and Benzodiazepine Discontinuation in Opioid Agonist Therapy, Phase 2
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Participant Acceptability of the Interventions
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 or older
- •Receiving OAT (methadone or buprenorphine) confirmed by toxicology testing for at least 90 days and on a steady dose for 2 consecutive 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
排除标准
- •Pregnant, confirmed by urine pregnancy test
- •Cognitive impairment, as indicated by a score of < 23 on the Mini Mental Status Exam
- •Any past month illicit opioid, barbiturate, z-drug, cocaine, unprescribed amphetamine, or synthetic cannabinoid use determined by self-report or urine drug test
- •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
研究组 & 干预措施
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) 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.
干预措施: Distress Tolerance - Benzodiazepine Discontinuation (DT-BD) (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) 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.
干预措施: BZD discontinuation protocol (Drug)
结局指标
主要结局
Participant Acceptability of the Interventions
时间窗: 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
时间窗: 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.
次要结局
- Completion of Intervention(13 weeks)
- BZD Use Based on Self-report(13 weeks)
- Illicit Drug Use Based on Urine Drug Tests(13 weeks)
- Alcohol Use Based on Urine Drug Tests(13 weeks)
- Alcohol Use Based on Self-report(13 weeks)
- BZD Withdrawal Symptoms(13 weeks)
- Anxiety Symptoms(13 weeks)
- Depressive Symptoms(13 weeks)
- Sleep Quality(13 weeks)
- Inability to Tolerate Negative States(13 weeks)
- Inflexibility or Experiential Avoidance(13 weeks)
- Fear of Anxiety Symptoms(13 weeks)
- Number of Participants Assessed for Distress Tolerance(13 weeks)
- Number of Participants Assessed for Motivations to Use BZD(13 weeks)