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)

Enrollment

Location

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 Disease	Intervention/Treatment	Phase
Substance Use Disorders Bipolar Disorder Mood Disorders	Drug: Quetiapine Drug: Placebo	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

Arm	Intervention/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.

Arm

Intervention/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

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
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

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.
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.
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:

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