Effectiveness of Extended Treatments for Drug Dependence

NCT00685659 | Completed Results

• 1 other identifier: R01DA020623
• Study Type: interventional
• Target: 332
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Cocaine Dependence

Keywords

cocaine dependence; treatment; continuing care; outcomes; incentives; adaptive

Outcome Measures

Primary Outcomes (27)

• 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 Outcomes (3)

• Participation in Protocol

  24 months

• HIV Sex Risk Score

  12 months

• HIV Sex Risk Score

  24 months

Study Arms (3)

TAU only

ACTIVE COMPARATOR

Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long)

Other: Intensive Outpatient Treatment

TMAC only

EXPERIMENTAL

Adaptive telephone-based counseling

Other: Adaptive telephone-based counseling

TMAC plus

EXPERIMENTAL

Adaptive telephone-based counseling, plus incentives

Other: Adaptive telephone-based counseling plus incentives

Interventions

Intensive Outpatient Treatment OTHER

9 hours of group counseling per week for 2-3 months

TAU only

Adaptive telephone-based counseling OTHER

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

TMAC only

Adaptive telephone-based counseling plus incentives OTHER

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

TMAC plus

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (2)

Presbyterian Hospital

Philadelphia, Pennsylvania, 19104, United States

Location

NorthEast Treatment Centers

Philadelphia, Pennsylvania, 19123, United States

Location

Related Publications (6)

• 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.

  PMID: 24041231 RESULT

• 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.

  PMID: 24355401 RESULT

• 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.

  PMID: 23561331 RESULT

• 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.

  PMID: 21041041 RESULT

• 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.

  PMID: 27224980 RESULT

• 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.

  PMID: 26621551 RESULT

MeSH Terms

Conditions

Cocaine-Related Disorders

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: James R. McKay, Ph.D.
• Organization: University of Pennsylvania

jimrache@mail.med.upenn.edu

215-746-7704

Study Officials

• James R McKay, Ph.D.

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2008
• First Posted: May 28, 2008
• Study Start: May 1, 2007
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: August 7, 2017
• Results First Posted: December 14, 2016

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)