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

Boston Medical Center (BMC)

Status and phase: Completed; Phase 4

Conditions: Bipolar Disorder; Substance Use Disorders; Mood Disorders

Treatments: Drug: Quetiapine; Other: Placebo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02845453

5K12DA000357-17 (U.S. NIH Grant/Contract)

H-39577

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 15 to 24 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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24 participants in 2 patient groups, including a placebo group

Quetiapine

Experimental group

Description:

Quetiapine

Treatment:

Drug: Quetiapine

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Other: Placebo