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Treatment With Quetiapine for Youth With Substance Use Disorders and Severe Mood Dysregulation

Primary Purpose

Substance Use Disorders, Bipolar Disorder, Mood Disorders

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Quetiapine
Placebo
Sponsored by
Boston Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Substance Use Disorders focused on measuring youth, adolescent, young adult, substance use disorder, bipolar disorder, quetiapine, mood dysregulation

Eligibility Criteria

15 Years - 24 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or female age 15 to 24
  • Meet DSM-5 criteria for a substance use disorder
  • Substance use ≥ 14 days of past 28 days (i.e. use ≥ 50% of days in the past 28 days)
  • If subject in restricted setting/care (e.g. inpatient detox unit or residential treatment) for ≤ 2 weeks, then use ≥ 50% of days while outside of restricted setting (e.g. 7 days of substance use out of 14 days in unrestricted setting)
  • Subjects need to have been in an unrestricted setting for at least 2 weeks prior to screening
  • Meets DSM-5 criteria for bipolar disorder or disruptive mood dysregulation disorder or DSM IV criteria for mood disorder not otherwise specified
  • Symptoms of SMD: Youth Self Report (YSR) or Adult Self Report (ASR) AAA ≥180
  • Stable to be treated in outpatient level of care

Exclusion Criteria:

  • Current methamphetamine use disorder
  • Current unstable opioid use disorder (i.e. < 3 months on medication assisted treatment for an opioid use disorder)
  • Pregnant or breastfeeding
  • Placement in a restricted setting (e.g. detox or residential treatment) for ≥ 2 weeks out of past 28 days prior to screening visit, or placement in a restricted setting at anytime during study participation
  • Unwilling or unable to use effective birth control
  • Unwilling or unable to sign release of information for the treatment program providing behavioral treatment
  • For participants >17 years-unable or unwilling to identify emergency contact

Sites / Locations

  • Boston Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Quetiapine

Placebo

Arm Description

Quetiapine

Placebo

Outcomes

Primary Outcome Measures

Change in Timeline Followback of Substance Use (TLFB)
The TLFB is used to quantify self-reported drug of choice use during the past month. Counts the number of days with substance use in the past 28 days.
Change in Symptoms of Mania
Symptoms of mania will be assessed using the Young Mania Rating Scale (YMRS). The YMRS consists of 11 items rated on a scale. Each item is composed of 5 explicitly defined levels of severity. Severity ratings for 7 items are scored on a scale of 0 -4. The remaining 4 items are double weighted to account for poor cooperation of client when unwell and are scored on a scale of 0 - 8. Item ratings are sum to produce a total YMRS score between 0 -60. Higher scores on the YMRS indicate greater symptoms of mania.

Secondary Outcome Measures

Change in the Number of Negative Urine Toxicology Specimens
Urine toxicology specimens for the participant's drug of choice assessed as positive or negative. For each participant, the proportion of urine toxicology specimens that are negative over the course of the trial are calculated as the number of negative specimens divided by the total number of specimens collected from week 1 until study endpoint.
Change in Craving for the Substance That the Participant Identifies as Most Problematic
Craving will be measured by the Weiss Craving Scale. This scale consists of 3 items rated on a scale from 0 (no desire/likelihood of use) to 9 (strong desire/likelihood of use). The total Weiss Craving Scale score ranges from 0 to 27. Higher scores on the Weiss Craving Scale indicate greater cravings for a substance.
Change in Symptoms of Depression
Symptoms of depression will be assessed using the Beck Depression Inventory II (BDI-II) scale. The BDI-II consists of 21 items rated on a scale from 0 (symptoms not present) to 3 (symptoms extremely severe). Total scores on the BDI-II range from 0 to 63. Higher scores indicate greater symptoms of depression.

Full Information

First Posted
July 14, 2016
Last Updated
April 19, 2022
Sponsor
Boston Medical Center
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT02845453
Brief Title
Treatment With Quetiapine for Youth With Substance Use Disorders and Severe Mood Dysregulation
Official Title
A Randomized Controlled Trial of Quetiapine for the Treatment of Youth With Co-occurring Substance Use Disorders and Severe Mood Dysregulation
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
January 20, 2017 (Actual)
Primary Completion Date
April 7, 2021 (Actual)
Study Completion Date
April 7, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Medical Center
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study proposes to use quetiapine as an adjunct treatment to treatment as usual to improve both substance use disorder (SUD) and mood symptoms in youth with SUD and severe mood dysregulation (SMD). This is a randomized, double blind placebo controlled parallel design study. Youth with symptoms of mood dysregulation and active substance use that meets criteria for a SUD will be randomized to adjunct treatment with quetiapine or placebo. The investigators hypothesize that treatment with quetiapine will lead to a reduction in substance use, improvement in mood, and lead to greater engagement in outpatient treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use Disorders, Bipolar Disorder, Mood Disorders
Keywords
youth, adolescent, young adult, substance use disorder, bipolar disorder, quetiapine, mood dysregulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Quetiapine
Arm Type
Experimental
Arm Description
Quetiapine
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Quetiapine
Other Intervention Name(s)
Seroquel
Intervention Description
Participants will be randomly assigned Quetiapine and will be titrated to the maximum daily dose over three weeks and then enter a dose maintenance phase for weeks 4 through 8 of the study.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Participants will be randomly assigned to placebo and will be titrated to the maximum daily dose over three weeks and then enter a dose maintenance phase for weeks 4 through 8 of the study.
Primary Outcome Measure Information:
Title
Change in Timeline Followback of Substance Use (TLFB)
Description
The TLFB is used to quantify self-reported drug of choice use during the past month. Counts the number of days with substance use in the past 28 days.
Time Frame
baseline, 8 weeks
Title
Change in Symptoms of Mania
Description
Symptoms of mania will be assessed using the Young Mania Rating Scale (YMRS). The YMRS consists of 11 items rated on a scale. Each item is composed of 5 explicitly defined levels of severity. Severity ratings for 7 items are scored on a scale of 0 -4. The remaining 4 items are double weighted to account for poor cooperation of client when unwell and are scored on a scale of 0 - 8. Item ratings are sum to produce a total YMRS score between 0 -60. Higher scores on the YMRS indicate greater symptoms of mania.
Time Frame
baseline, 8 weeks
Secondary Outcome Measure Information:
Title
Change in the Number of Negative Urine Toxicology Specimens
Description
Urine toxicology specimens for the participant's drug of choice assessed as positive or negative. For each participant, the proportion of urine toxicology specimens that are negative over the course of the trial are calculated as the number of negative specimens divided by the total number of specimens collected from week 1 until study endpoint.
Time Frame
baseline, 8 weeks
Title
Change in Craving for the Substance That the Participant Identifies as Most Problematic
Description
Craving will be measured by the Weiss Craving Scale. This scale consists of 3 items rated on a scale from 0 (no desire/likelihood of use) to 9 (strong desire/likelihood of use). The total Weiss Craving Scale score ranges from 0 to 27. Higher scores on the Weiss Craving Scale indicate greater cravings for a substance.
Time Frame
baseline, 8 weeks
Title
Change in Symptoms of Depression
Description
Symptoms of depression will be assessed using the Beck Depression Inventory II (BDI-II) scale. The BDI-II consists of 21 items rated on a scale from 0 (symptoms not present) to 3 (symptoms extremely severe). Total scores on the BDI-II range from 0 to 63. Higher scores indicate greater symptoms of depression.
Time Frame
baseline, 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female age 15 to 24 Meet DSM-5 criteria for a substance use disorder Substance use ≥ 14 days of past 28 days (i.e. use ≥ 50% of days in the past 28 days) If subject in restricted setting/care (e.g. inpatient detox unit or residential treatment) for ≤ 2 weeks, then use ≥ 50% of days while outside of restricted setting (e.g. 7 days of substance use out of 14 days in unrestricted setting) Subjects need to have been in an unrestricted setting for at least 2 weeks prior to screening Meets DSM-5 criteria for bipolar disorder or disruptive mood dysregulation disorder or DSM IV criteria for mood disorder not otherwise specified Symptoms of SMD: Youth Self Report (YSR) or Adult Self Report (ASR) AAA ≥180 Stable to be treated in outpatient level of care Exclusion Criteria: Current methamphetamine use disorder Current unstable opioid use disorder (i.e. < 3 months on medication assisted treatment for an opioid use disorder) Pregnant or breastfeeding Placement in a restricted setting (e.g. detox or residential treatment) for ≥ 2 weeks out of past 28 days prior to screening visit, or placement in a restricted setting at anytime during study participation Unwilling or unable to use effective birth control Unwilling or unable to sign release of information for the treatment program providing behavioral treatment For participants >17 years-unable or unwilling to identify emergency contact
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amy Yule, M.D.
Organizational Affiliation
Boston Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Treatment With Quetiapine for Youth With Substance Use Disorders and Severe Mood Dysregulation

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