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ITAP + SAFE for Bipolar and Substance Use Disorders (ITAP Trial)

Waitlist Available
Led By Brandon Gaudiano, PhD
Research Sponsored by Butler Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Taking at least one mood-stabilizing medication
Diagnosis of a bipolar-spectrum disorder
Must not have
Younger than age 18
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights


This trial is testing a new way to help people with bipolar disorder and addiction. Half the group will get a new program to help them, while the other half will just get closer monitoring.

Who is the study for?
This trial is for adults with both bipolar disorder and a substance use disorder who are on mood-stabilizing medication. Participants must be able to speak and read English. It's not suitable for individuals under the age of 18.Check my eligibility
What is being tested?
The study tests two programs: ITAP, a specialized psychosocial intervention, versus SAFE, an enhanced safety monitoring program. Both are in addition to routine care after psychiatric hospitalization for those with co-occurring disorders.See study design
What are the potential side effects?
Since this trial involves psychosocial interventions rather than medications, traditional side effects like you'd see with drugs aren't expected. However, participants may experience stress or discomfort discussing personal issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
I am currently taking medication to stabilize my mood.
I have been diagnosed with a bipolar disorder.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
I am under 18 years old.


Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Clinician-Administered Rating Scale for Mania (CARS-M)
Quick Inventory of Depressive Symptomatology - Clinician Rating (QIDS-C)

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Integrated Treatment Adherence Program (ITAP)Experimental Treatment1 Intervention
A combination of in-person and phone sessions along with significant other involvement over 6 months post-hospitalization.
Group II: Safety Assessment and Follow-up Evaluation (SAFE)Active Control1 Intervention
Enhanced symptom monitoring and safety evaluation over 6 months post-hospitalization.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Bipolar Disorder include pharmacological and psychosocial interventions. Mood stabilizers like lithium work by modulating neurotransmitter activity to stabilize mood swings, while antipsychotics target dopamine and serotonin receptors to manage manic and depressive symptoms. Psychosocial interventions, such as cognitive-behavioral therapy (CBT), focus on changing negative thought patterns and behaviors, improving emotional regulation and coping strategies. These treatments are essential for Bipolar Disorder patients as they address both the biological and psychological aspects of the disorder, leading to more comprehensive and effective symptom management.

Find a Location

Who is running the clinical trial?

Butler HospitalLead Sponsor
130 Previous Clinical Trials
16,333 Total Patients Enrolled
4 Trials studying Bipolar Disorder
227 Patients Enrolled for Bipolar Disorder
National Institute of Mental Health (NIMH)NIH
2,820 Previous Clinical Trials
2,692,659 Total Patients Enrolled
146 Trials studying Bipolar Disorder
63,925 Patients Enrolled for Bipolar Disorder
Brandon Gaudiano, PhDPrincipal InvestigatorButler Hospital
7 Previous Clinical Trials
353 Total Patients Enrolled
1 Trials studying Bipolar Disorder
180 Patients Enrolled for Bipolar Disorder
~3 spots leftby Aug 2024