Early Re-Intervention Experiment 2

Substance Use Disorders Clinical Trial

— ERI2  

Official title:

Early Re-Intervention (ERI) Experiment 2

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01153594
• Other study ID #: ERI-2
• Secondary ID: 5R37DA011323
• Status: Completed
• Phase: Phase 3
• First received: June 29, 2010
• Last updated: June 29, 2010
• Start date: February 2004
• Est. completion date: June 2009

Study information

• Verified date: June 2010
• Source: Chestnut Health Systems
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

The objective of this study was to evaluate the relative effectiveness of quarterly Recovery Management Checkups (RMC) on long-term outcomes of adult chronic substance users over 4 years.

Description:

CONTEXT: While drug abuse is the 10th leading cause of mortality in the US, the disorder remains an orphan of the public health care system. Unlike cancer, diabetes, and other chronic diseases, the detection, re-emergence, and progression of which we have learned to respond with aggressively timed monitoring and interventions, drug abuse remains isolated from adoption into the "chronic condition" model of care.

OBJECTIVES AND HYPOTHESES: The objective of this study was to evaluate the relative effectiveness of quarterly checkups on long-term outcomes of adult chronic substance users over 4 years. Relative to participants randomly assigned to the control group, we predicted that RMC participants would: H1) return to treatment sooner, H2) receive more treatment, H3) decrease substance use, and H4) increase days of abstinence.

METHOD: Participants were recruited from sequential intakes at the largest addiction treatment agency in Illinois between February and April of 2004. Inclusion criteria were: any substance use in the past 90 days and any past-year symptoms of substance use disorders. For logistical reasons, participants were excluded if they were: under 18, lived or planned to move outside Chicago within 12 months, sentenced to a confined environment most of the next 12 months, mandated to treatment because of a driving under the influence offense, were not fluent in English or Spanish, or were cognitively unable to provide informed consent. To evaluate efficacy of quarterly Recovery Management Checkups (RMC) on treatment reentry and substance use, 446 adults (88% with dependence criteria) were randomly assigned quarterly RMCs, or, an outcome monitoring only control group and followed quarterly for 4 years (94% completion).

INTERVENTION. After interviewers completed the quarterly research interview and determined participants' eligibility and need for early re-intervention, they transferred RMC participants who were eligible and in need to a Linkage Manager. Using motivational interviewing, the Linkage Manager: a) provided feedback to participants regarding their current substance use and related problems, b) discussed implications of managing addiction as a chronic condition, c) discussed treatment barriers and solutions, d) assessed and discussed level of motivation for treatment, e) scheduled treatment appointments, f) accompanied participants to treatment intake and stayed through the process, and g) implemented Engagement and Retention Protocol during the 14 days of treatment. Detailed procedures and forms are available in the RMC manual(Scott & Dennis, 2003; http://www.chestnut.org/LI/downloads/Scott_&_Dennis_2003_RMC_Manual-2_25_03.pdf ).

OUTCOME MEASURES: Days to first treatment, days of treatment, successive quarters of needing treatment, number of substance problem months, days of abstinence.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 446
• Est. completion date: June 2009
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• any substance use in the past 90 days

• any past-year symptoms of substance use disorders.

Exclusion Criteria:

• under 18

• lived or planned to move outside Chicago within 12 months

• sentenced to a confined environment most of the next 12 months

• mandated to treatment because of a driving under the influence offense

• were not fluent in English or Spanish

• were cognitively unable to provide informed consent.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Substance Use Disorders
• Substance-Related Disorders

Intervention

Behavioral:
• Recovery Management Checkups (RMC)
After interviewers completed the quarterly research interview and determined participants' eligibility and need for early re-intervention, they transferred RMC participants who were eligible and in need to a Linkage Manager. Using motivational interviewing, the Linkage Manager: a) provided feedback to participants regarding their current substance use and related problems, b) discussed implications of managing addiction as a chronic condition, c) discussed treatment barriers and solutions, d) assessed and discussed level of motivation for treatment, e) scheduled treatment appointments, f) accompanied participants to treatment intake and stayed through the process, and g) implemented Engagement and Retention Protocol during the 14 days of treatment

Locations

Country	Name	City	State
United States	Chestnut Health Systems	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Chestnut Health Systems	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

References & Publications (5)

Dennis M, Scott CK. Managing addiction as a chronic condition. Addict Sci Clin Pract. 2007 Dec;4(1):45-55. — View Citation

Rush BR, Dennis ML, Scott CK, Castel S, Funk RR. The interaction of co-occurring mental disorders and recovery management checkups on substance abuse treatment participation and recovery. Eval Rev. 2008 Feb;32(1):7-38. doi: 10.1177/0193841X07307532. — View Citation

Scott CK, Dennis ML. Results from two randomized clinical trials evaluating the impact of quarterly recovery management checkups with adult chronic substance users. Addiction. 2009 Jun;104(6):959-71. doi: 10.1111/j.1360-0443.2009.02525.x. Epub 2009 Mar 13 — View Citation

Scott CK, Sonis J, Creamer M, Dennis ML. Maximizing follow-up in longitudinal studies of traumatized populations. J Trauma Stress. 2006 Dec;19(6):757-69. — View Citation

Scott, C.K. Dennis, M.L. (in press). Recovery Management Checkups with adult chronic substance users. In Kelly, J.F., and White, W.L. (Eds), Addiction Recovery Management: Theory, Research, and Practice. New York, NY: Springer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to First Alcohol or Drug Treatment Re-Entry	Days to readmission was calculated as the number of days from the date of the quarterly follow-up interview where the client first reported being in need of treatment (see below) to the date of the first subsequent intake to alcohol or other drug treatment following that interview.	Quarterly from random assignment until month 48	No
Secondary	Any Treatment Re-Entry	Whether the person re-entered treatment between the point of randomization (at 3 months) and last observation.	Quarterly from random assignment until month 48	No
Secondary	Times Re-entered Treatment Time Frame	Number of times client re-entered treatment between randomization and the last observation.	Quarterly from random assignment until month 48 Description:	No
Secondary	Total Days of Treatment	Based on the sum of days an individual received outpatient, intensive outpatient, residential, or inpatient treatment reported at each interview for a given period.	Quarterly from random assignment until month 48	No
Secondary	Quarters with 7 days Outpatient or 14 days Residential	The number of quarters a participant received treatment at least 7 days of outpatient or 14 days of residential treatment, regardless of whether it is due to retention, step down or readmission.	Quarterly from random assignment until month 48	No
Secondary	Quarters Needing Treatment	Defined as a participant living in the community (vs. in incarcerated) who was not already in treatment and had been intoxicated or used alcohol or drugs on 13 or more of the past 90 days; had any symptoms of abuse, dependence, or withdrawal in the past month; or currently felt the need to return to treatment. Within quarter these criteria for need are internally consistent (alpha=.85) and the average person in need endorsed 3.3 of 6 of the items (80% endorsed 2 or more).	Quarterly from random assignment until month 48	No
Secondary	Successive Quarters Needing Treatment	The number of quarters in which the individual started and ended the period "in need of treatment" (see definition above) where missing data were replaced with status at prior wave.	Quarterly from random assignment until month 48	No
Secondary	Substance Problem x Months	Count of 16 past-month item related to weekly use, hiding using, complaints about use, 4 symptoms of abuse, 7 symptoms of dependence, substance induced health or mental health asked for the month before each quarterly interview times 3 and summed over observations; using mean score for any missing observations.	Quarterly from random assignment until month 48	No
Secondary	Total Days of Abstinence	Sum of days abstinent from alcohol or other drugs in months 4 to 48 (max=1350 days); using the mean days per quarter for any missing observations.	Quarterly from random assignment until month 48	No