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

Sponsor
Boston Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT02845453
Collaborator
National Institute on Drug Abuse (NIDA) (NIH)
19
Enrollment
1
Location
2
Arms
50.5
Actual Duration (Months)
0.4
Patients Per Site Per Month

Study Details

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.

Condition or DiseaseIntervention/TreatmentPhase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
19 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Randomized Controlled Trial of Quetiapine for the Treatment of Youth With Co-occurring Substance Use Disorders and Severe Mood Dysregulation
Actual Study Start Date :
Jan 20, 2017
Actual Primary Completion Date :
Apr 7, 2021
Actual Study Completion Date :
Apr 7, 2021

Arms and Interventions

ArmIntervention/Treatment
Experimental: Quetiapine

Quetiapine

Drug: Quetiapine
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.
Other Names:
  • Seroquel
  • Placebo Comparator: Placebo

    Placebo

    Drug: Placebo
    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.

    Outcome Measures

    Primary Outcome Measures

    1. Change in the number of days of most problematic substance use in the previous month [baseline, 8 weeks]

      The number of days of substance use over the past month for the substance that the participant identifies as most problematic will be assessed by participants' self report

    2. Change in symptoms of mania [baseline, 8 weeks]

      Symptoms of mania will be assessed using the Young Mania Rating Scale (YMRS). The YMRS consists of 11 items rated on a scale from 0 (symptoms not present) to 4 (symptoms extremely severe). The total YMRS score ranges from 0 to 60. Higher scores on the YMRS indicate greater symptoms of mania.

    Secondary Outcome Measures

    1. Change in the number of negative urine toxicology specimens [baseline, 8 weeks]

      The number of negative urine toxicology specimens will be assessed for the substance that the participant identifies as most problematic.

    2. Change in craving for the substance that the participant identifies as most problematic [baseline, 8 weeks]

      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.

    3. Change in symptoms of Depression [baseline, 8 weeks]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    15 Years to 24 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Boston Medical CenterBostonMassachusettsUnited States02118

    Sponsors and Collaborators

    • Boston Medical Center
    • National Institute on Drug Abuse (NIDA)

    Investigators

    • Study Chair: Amy Yule, M.D., Boston Medical Center

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Boston Medical Center
    ClinicalTrials.gov Identifier:
    NCT02845453
    Other Study ID Numbers:
    • H-39577
    • 5K12DA000357-17
    First Posted:
    Jul 27, 2016
    Last Update Posted:
    Jul 6, 2021
    Last Verified:
    Jul 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Keywords provided by Boston Medical Center
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 6, 2021