Developing an Intervention to Address Suicide Risk During Substance Use Disorder

Substance-Related Disorders Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01127932
• Other study ID #: 5R21DA026925-02
• Status: Completed
• Phase: N/A
• First received: May 20, 2010
• Last updated: May 11, 2015
• Start date: April 2010
• Est. completion date: September 2011

Study information

• Verified date: May 2015
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This is a 2-year study designed to: (1) adapt and refine an existing cognitive-behavioral treatment (CBT) intervention to decrease suicidal thoughts and behaviors for use in Substance Use Disorder (SUD) treatment settings, and (2) conduct a pilot randomized controlled trial with 50 patients in treatment for SUDs comparing the CBT intervention to an enhanced control condition. Through this pilot randomized controlled trial, the investigators hope to not only obtain information about the feasibility of implementing these procedures in residential SUD treatment, but to also determine whether this intervention decreases the level of suicidal ideation, suicide attempts, hopelessness, and frequency of substance use relative to the control condition.

Description:

Existing research indicates that problematic alcohol and drug use are closely linked to both fatal and non-fatal suicide attempts. Given the strong association between substance use and suicide, an episode of substance use disorder (SUD) treatment provides a unique opportunity to decrease the likelihood of suicidal behaviors. However, there are no data on the effectiveness of specific interventions designed to decrease suicidal thoughts and behaviors during an episode of SUD treatment in individuals at high risk for suicide. Patients for this trial will be screened at the SUD treatment site for a combination of a past suicide attempt and current suicidal ideation and will be randomized to CBT or control conditions. All participants in the pilot randomized controlled trial will be assessed at baseline, at the end of treatment, and at a 3-month follow-up. From a public health perspective, SUD treatment programs contain large numbers of patients at high risk for future suicidal behaviors and therefore have the potential to play a central role in our nation's efforts to decrease suicide.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: September 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Must be over 18 years of age

• Report a past lifetime suicide attempt

• Report current suicidal ideation

• Resided in treatment for less than 4 weeks

• In treatment for less than 6 months

Exclusion Criteria:

• Mental incompetence (e.g. unable to provide informed consent)

• Diagnosis of schizophrenia or currently psychotic

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Substance-Related Disorders
• Suicide

Intervention

Behavioral:
• Psychoeducation for substance abuse
This active control provides detailed information about substance use, suicide risk, and depression to those enrolled.
• CBT for suicide in Substance abuse
The therapeutic intervention group is designed to provide beneficial coping strategies that are helpful in dealing with both substance use and suicidal thoughts.

Locations

Country	Name	City	State
United States	Community Programs, INC.	Waterford	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Level of Suicidal Ideation		Six months	No