|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03526354|
Recruitment Status : Recruiting
First Posted : May 16, 2018
Last Update Posted : June 22, 2020
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia Schizoaffective Disorder Substance Use Disorders||Drug: Brexpiprazole Other: Treatment as Usual||Phase 4|
The primary objectives of the study include:
- examine the effect of brexpiprazole treatment on the number of days of substance use in the past week as measured by the Timeline Follow-Back (TLFB) assessment;
- examine the effect of brexpiprazole treatment on substance craving using 100-mm visual analogue scale (VAS).
The secondary objectives are to examine the effect of brexpiprazole treatment on:
- the dollar amount spent on substances in the past week;
- the psychiatric symptoms as measured using PANSS
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multi-center, Randomized, Controlled Trial of Brexpiprazole for the Treatment of Co-occurring Schizophrenia and Substance Use Disorder|
|Actual Study Start Date :||March 19, 2018|
|Estimated Primary Completion Date :||March 19, 2022|
|Estimated Study Completion Date :||September 19, 2022|
Brexpiprazole 4mg daily for 12 weeks
Brexpiprazole 4mg daily for 12 weeks
Other Name: Study Medication
Active Comparator: Treatment as Usual
Stay on current antipsychotic medication for 12 weeks
Other: Treatment as Usual
Current antipsychotic medication for 12 weeks
Other Name: Current Antipsychotic Treatment
- Time line Follow back (TLFB) [ Time Frame: 12 weeks ]
A scale used to measure weekly substance use starting 30 days prior to the screening until the end of the 12-week study period. Measurement values for the scale vary based on substance used (i.e. alcohol = number of standard drinks/ day; Cannabis = number of joints/ day; cocaine and heroine = did you use this day), but for our purposes data collected will be reduced to whether or not a subject used on a particular day.
For this study, a decrease in the number of days of substance use over a 7-day period will be considered an improved outcome.
- Visual Analog Scale [ Time Frame: 12 weeks ]
measure to assess craving for substances. Subjects will make a mark on an unlabeled 100 millimeter line indicating their desire to use a particular substance over the past 7-days. A score of 0 indicates no desire to use and 100 indicating the strongest desire to use possible.
This assessment will be taken on a weekly basis throughout the 12-week study. Every substance that a subject has a substance use disorder for will be measured separately.
For this study a decreased score represents an improved outcome.
- Amount of money spent on substances [ Time Frame: 12 weeks ]The amount of money spent on substances over a 7-day period will also be recorded as part of each weekly visit. Decreased money spent on substances over a 7-day period will also be considered an improved outcome.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03526354
|Contact: Mathew Chiang, BA||508-856-8323||Mathew.firstname.lastname@example.org|
|United States, Massachusetts|
|Massachusetts General Hospital||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Contact: Caroline Kale, BA 617-912-7864 email@example.com|
|Principal Investigator: Oliver Freudenreich, MD|
|UMass Medical School||Recruiting|
|Worcester, Massachusetts, United States, 01655|
|Contact: Mathew Chiang, BA 508-856-8323 firstname.lastname@example.org|
|Principal Investigator: Xiaoduo Fan, MD|
|United States, North Carolina|
|University of North Carolina||Recruiting|
|Chapel Hill, North Carolina, United States, 27599|
|Contact: Fred Jarskog, MD|
|Principal Investigator:||Xiaoduo Fan, MD||University of Massachusetts, Worcester|