Clinical trial NCT02845453: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Substance Use Disorders
Bipolar Disorder
Mood Disorders
Keywords: youth
adolescent
young adult
substance use disorder
bipolar disorder
quetiapine
mood dysregulation
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2016-07-27
Enrollment: 24
Sex: ALL
Minimum age (years): 15
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in Timeline Followback of Substance Use (TLFB)
timeFrame: baseline, 8 weeks
measure: Change in Symptoms of Mania
timeFrame: baseline, 8 weeks
Secondary outcomes:
measure: Change in the Number of Negative Urine Toxicology Specimens
timeFrame: baseline, 8 weeks
measure: Change in Craving for the Substance That the Participant Identifies as Most Problematic
timeFrame: baseline, 8 weeks
measure: Change in Symptoms of Depression
timeFrame: baseline, 8 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: Boston Medical Center
name: Amy Yule, M.D.
role: STUDY_CHAIR
References: