Print

Purpose

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.

Conditions

Eligibility

Eligible Ages
Between 15 Years and 24 Years
Eligible Genders
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

Study Design

Phase
Phase 4
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
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
  • Other: 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.

More Details

Status
Completed
Sponsor
Boston Medical Center

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.