Effectiveness of Extended Treatments for Drug Dependence (ETDD)

This study tests the effectiveness of two 24 month, telephone-based adaptive continuing care interventions for patients with cocaine dependence. The two interventions are predicted to produce better drug use outcomes than standard care. Furthermore, the intervention that also includes monetary incentives for continued participation is hypothesized to produce better retention and drug use outcomes than the intervention without incentives. Economic analyses will determine the cost-effectiveness and benefit-cost of the interventions relative to standard care, and to each other.

Study Overview

• Status: Completed
• Conditions: Cocaine Dependence
• Intervention / Treatment: Other: Intensive Outpatient Treatment; Other: Adaptive telephone-based counseling; Other: Adaptive telephone-based counseling plus incentives

Detailed Description

There is considerable evidence that treatment for drug use disorders can lead to substantial improvements in substance use and psychosocial problem severity. However, a significant percentage of patients relapse to problematic levels of substance use after primary treatment, and require additional treatment episodes. Patients are therefore frequently referred to continuing care programs to prevent relapse and decrease the probability of additional rehabilitation treatments. However, current models of continuing care may not be adequate for the long-term management of a chronic, relapsing disorder such as substance dependence. One possible approach for improving the management of drug dependence is adaptive treatment regimes, which combine low intensity monitoring and counseling when patients are doing well with stepped care protocols to increase the intensity of treatment when warranted by deteriorations in status and functioning. However, addiction management protocols may require incentives and other features to make long-term participation more appealing.

Cocaine dependent patients who have completed 2 weeks of intensive outpatient treatment (IOP) will be randomly assigned to one of the following interventions: (1) continued participation in IOP without additional intervention (TAU); (2) TAU plus an adaptive protocol that includes monitoring, feedback, and brief counseling via telephone on a tapered schedule out to 24 months, and more intensive face-to-face treatment when warranted (TMAC); or (3) TAU and the adaptive protocol, plus incentives for sustained participation (TMAC-Plus). Patients will be followed up at 3, 6, 9, 12, 18, and 24 months post intake into the study. Follow-up assessments will include measures of drug use, treatment process and potential mediating factors, psychosocial problem severity, utilization of health and social services, and costs.

The two adaptive extended interventions (TMAC and TMAC-Plus) are predicted to produce better drug use outcomes than TAU. TMAC-Plus is hypothesized to produce better retention and drug use outcomes than TMAC. Economic analyses will determine the cost-effectiveness and benefit-cost of TMAC and TMF-Plus relative to TAU, and to each other. Other analyses will test mediation hypotheses, examine potential moderator effects, and test the impact of disease management on HIV risk behaviors.

• Study Type: Interventional
• Enrollment (Actual): 332
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Presbyterian Hospital
    • Philadelphia, Pennsylvania, United States, 19123
      • NorthEast Treatment Centers

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• qualify for a DSM-IV lifetime diagnosis of cocaine dependence and cocaine use in 6 months prior to treatment;
• initial engagement in IOP, as indicated by attendance at 4 or more sessions in the first two weeks of treatment;
• 18 to 75 years of age;
• willingness to be randomized and participate in research.
• metropolitan area residents;
• able to provide the name, verified telephone number, and address of at least one contact who can provide locator information on the patient during follow-up.

Exclusion Criteria:

• current psychotic disorder or evidence of dementia severe enough to prevent participation in outpatient treatment;
• acute medical problem requiring immediate inpatient treatment;
• current participation in methadone or other forms of DA treatment, other than IOP

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: TAU only; Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long)	Other: Intensive Outpatient Treatment; 9 hours of group counseling per week for 2-3 months
Experimental: TMAC only; Adaptive telephone-based counseling	Other: Adaptive telephone-based counseling; In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included
Experimental: TMAC plus; Adaptive telephone-based counseling, plus incentives	Other: Adaptive telephone-based counseling plus incentives; In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Abstinence	Abstinence as reported on Addiction Severity Index, Timeline Follow up, and as tested on the urine drug screen. Measure was created as such: if on ASI the participant reported no use, and on the TLFB the participant reported no use, and on the urine drug screen there was no substances detected, then the participant is considered abstinent. If there is use indicated on any one or all of those items (ASI, TLFB, UDS) then the participant is not abstinent.	3 month follow up
Abstinence	Abstinence as reported on Addiction Severity Index, Timeline Follow up, and as tested on the urine drug screen. Measure was created as such: if on ASI the participant reported no use, and on the TLFB the participant reported no use, and on the urine drug screen there was no substances detected, then the participant is considered abstinent. If there is use indicated on any one or all of those items (ASI, TLFB, UDS) then the participant is not abstinent.	6 month follow up
Abstinence	Abstinence as reported on Addiction Severity Index, Timeline Follow up, and as tested on the urine drug screen. Measure was created as such: if on ASI the participant reported no use, and on the TLFB the participant reported no use, and on the urine drug screen there was no substances detected, then the participant is considered abstinent. If there is use indicated on any one or all of those items (ASI, TLFB, UDS) then the participant is not abstinent.	9 month follow up
Abstinence	Abstinence as reported on Addiction Severity Index, Timeline Follow up, and as tested on the urine drug screen. Measure was created as such: if on ASI the participant reported no use, and on the TLFB the participant reported no use, and on the urine drug screen there was no substances detected, then the participant is considered abstinent. If there is use indicated on any one or all of those items (ASI, TLFB, UDS) then the participant is not abstinent.	12 month follow up
Abstinence	Abstinence as reported on Addiction Severity Index, Timeline Follow up, and as tested on the urine drug screen. Measure was created as such: if on ASI the participant reported no use, and on the TLFB the participant reported no use, and on the urine drug screen there was no substances detected, then the participant is considered abstinent. If there is use indicated on any one or all of those items (ASI, TLFB, UDS) then the participant is not abstinent.	18 month follow up
Abstinence	Abstinence as reported on Addiction Severity Index, Timeline Follow up, and as tested on the urine drug screen. Measure was created as such: if on ASI the participant reported no use, and on the TLFB the participant reported no use, and on the urine drug screen there was no substances detected, then the participant is considered abstinent. If there is use indicated on any one or all of those items (ASI, TLFB, UDS) then the participant is not abstinent.	24 month follow up
Cocaine Urine Toxicology	Positive cocaine test of urine	3 month follow up
Cocaine Urine Toxicology	Positive cocaine test of urine	6 month follow up
Cocaine Urine Toxicology	Positive cocaine test of urine	9 month follow up
Cocaine Urine Toxicology	Positive cocaine test of urine	12 month follow up
Cocaine Urine Toxicology	Positive cocaine test of urine	18 month follow up
Cocaine Urine Toxicology	Positive cocaine test of urine	24 month follow up
Comparison Across Groups in Societal Costs	Total savings/spending calculated as the monetary value of days of illegal activity, days experiencing medical problems, days experiencing psychiatric problems, and days in jail captured with the ASI. Presented in 2008 dollars.	24 months
Net Saving/Spending Comparisons Across Groups From Provider Perspective	Savings minus intervention costs. Presented in 2008 dollars.	24 months
Net Comparisons of Savings and Spendings Across Groups From Societal Perspective	Savings minus intervention costs. Presented in 2008 dollars.	24 months
Percent Days Cocaine Use	Percent of days during the follow up that there was any cocaine use	3 months (approximately study days 1 - 90)
Percent Days Cocaine Use	Percent of days during the follow up that there was any cocaine use	6 months (approproximately study days 91 - 180)
Percent Days Cocaine Use	Percent of days during the follow up that there was any cocaine use	9 months (approximately study days 181 - 270)
Percent Days Cocaine Use	Percent of days during the follow up that there was any cocaine use	12 months (approximately study days 271 - 365)
Percent Days Cocaine Use	Percent of days during the follow up that there was any cocaine use	18 months (approximately study days 366 - 546)
Percent Days Cocaine Use	Percent of days during the follow up that there was any cocaine use	24 months (approximately study days 547 - 730)
Percent Days Abstinent	Percent of days during the follow up that participant was abstinent from Alcohol and Cocaine	3 months (approximately study days 1 - 90)
Percent Days Abstinent	Percent of days during the follow up that participant was abstinent from Alcohol and Cocaine	6 months (approximately study days 91 - 180)
Percent Days Abstinent	Percent of days during the follow up that participant was abstinent from Alcohol and Cocaine	9 months (approximately study days 181 - 270)
Percent Days Abstinent	Percent of days during the follow up that participant was abstinent from Alcohol and Cocaine	12 months (approximately study days 271 - 365)
Percent Days Abstinent	Percent of days during the follow up that participant was abstinent from Alcohol and Cocaine	18 months (approximately days 366 - 546)
Percent Days Abstinent	Percent of days during the follow up that participant was abstinent from Alcohol and Cocaine	24 months (approximately study days 547 - 730)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participation in Protocol	Percent available sessions completed	24 months
HIV Sex Risk Score	Risk score from RAB: Risk Assessment Battery. The RAB is a 41 - item self report developed to study the transmission of HIV. The Risk Assessment Battery generates a drug-risk score and a sex-risk score. For this study, the sex-risk score was used as the outcome measure of sexual behavior that is associated with HIV transmission. The sex-risk score ranges from 0 to 18, with 0 denoting no sex-risk and 18 denoting highest sex-risk. Previous research among drug using populations have found a sex-risk score mean of 6.2.	12 months
HIV Sex Risk Score	Risk score from RAB: Risk Assessment Battery. The RAB is a 41 - item self report developed to study the transmission of HIV. The Risk Assessment Battery generates a drug-risk score and a sex-risk score. For this study, the sex-risk score was used as the outcome measure of sexual behavior that is associated with HIV transmission. The sex-risk score ranges from 0 to 18, with 0 denoting no sex-risk and 18 denoting highest sex-risk. Previous research among drug using populations have found a sex-risk score mean of 6.2.	24 months

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: James R McKay, Ph.D., University of Pennsylvania

Publications and helpful links

General Publications

• McKay JR, Van Horn DH, Lynch KG, Ivey M, Cary MS, Drapkin ML, Coviello DM, Plebani JG. An adaptive approach for identifying cocaine dependent patients who benefit from extended continuing care. J Consult Clin Psychol. 2013 Dec;81(6):1063-73. doi: 10.1037/a0034265. Epub 2013 Sep 16.
• McKay JR, Van Horn DH, Lynch KG, Ivey M, Cary MS, Drapkin M, Coviello D. Who benefits from extended continuing care for cocaine dependence? Addict Behav. 2014 Mar;39(3):660-8. doi: 10.1016/j.addbeh.2013.11.019. Epub 2013 Dec 1.
• McKay JR, Van Horn D, Rennert L, Drapkin M, Ivey M, Koppenhaver J. Factors in sustained recovery from cocaine dependence. J Subst Abuse Treat. 2013 Aug;45(2):163-72. doi: 10.1016/j.jsat.2013.02.007. Epub 2013 Apr 2.
• Van Horn DH, Drapkin M, Ivey M, Thomas T, Domis SW, Abdalla O, Herd D, McKay JR. Voucher incentives increase treatment participation in telephone-based continuing care for cocaine dependence. Drug Alcohol Depend. 2011 Apr 1;114(2-3):225-8. doi: 10.1016/j.drugalcdep.2010.09.007. Epub 2010 Nov 1.
• Wimberly AS, Ivey M, Rennert L, McKay JR. Effect of Continuing Care for Cocaine Dependence on HIV Sex-Risk Behaviors. AIDS Behav. 2017 Apr;21(4):1082-1090. doi: 10.1007/s10461-016-1434-6.
• McCollister K, Yang X, McKay JR. Cost-effectiveness analysis of a continuing care intervention for cocaine-dependent adults. Drug Alcohol Depend. 2016 Jan 1;158:38-44. doi: 10.1016/j.drugalcdep.2015.10.032. Epub 2015 Nov 12.

Study record dates

Study Major Dates

• Study Start: May 1, 2007
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: May 23, 2008
• First Submitted That Met QC Criteria: May 23, 2008
• First Posted (Estimate): May 28, 2008

Study Record Updates

• Last Update Posted (Actual): August 7, 2017
• Last Update Submitted That Met QC Criteria: June 28, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: treatment; outcomes; cocaine dependence; incentives; continuing care; adaptive
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Cocaine-Related Disorders
• Other Study ID Numbers: R01DA020623 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO