Recruitment

Recruitment Status
Enrolling by invitation
Estimated Enrollment
Same as current

Summary

Conditions
Substance Use Disorders
Type
Interventional
Phase
Phase 2
Design
Allocation: Non-RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

This study pilots two 12-week psychosocial interventions each paired with identical benzodiazepine tapers with the aim of assisting individuals receiving OAT discontinue benzodiazepine use. All participants will receive the same benzodiazepine (BZD) discontinuation protocol; the only difference will...

This study pilots two 12-week psychosocial interventions each paired with identical benzodiazepine tapers with the aim of assisting individuals receiving OAT discontinue benzodiazepine use. All participants will receive the same benzodiazepine (BZD) discontinuation protocol; the only difference will be whether they receive the DT or RT interventions. There is no randomization process and the trial will be open label. Participants will be assigned one of the two interventions with the first participant receiving the DT-BD intervention, followed by the next participant receiving the RT intervention, and so on in that pattern. Specifically, among the eight participants, four will receive the DT-BD intervention and four will receive the RT intervention. The RT intervention has been utilized in past BZD discontinuation clinical trials and was found to be an adequate control intervention. Both interventions consist of 12 weeks with 3 weekly therapy sessions prior to an 8-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 12 weeks.

Tracking Information

NCT #
NCT04109118
Collaborators
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Tae Woo Park, MD Boston Medical Center