Clinical trial NCT00685659: Effectiveness of Extended Treatments for Drug Dependence
Official title: Effectiveness of Extended Treatments for Drug Dependence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cocaine Dependence
Keywords: cocaine dependence
treatment
continuing care
outcomes
incentives
adaptive
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2008-05-28
Enrollment: 332
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Abstinence
timeFrame: 3 month follow up
measure: Abstinence
timeFrame: 6 month follow up
measure: Abstinence
timeFrame: 9 month follow up
measure: Abstinence
timeFrame: 12 month follow up
measure: Abstinence
timeFrame: 18 month follow up
measure: Abstinence
timeFrame: 24 month follow up
measure: Cocaine Urine Toxicology
timeFrame: 3 month follow up
measure: Cocaine Urine Toxicology
timeFrame: 6 month follow up
measure: Cocaine Urine Toxicology
timeFrame: 9 month follow up
measure: Cocaine Urine Toxicology
timeFrame: 12 month follow up
measure: Cocaine Urine Toxicology
timeFrame: 18 month follow up
measure: Cocaine Urine Toxicology
timeFrame: 24 month follow up
measure: Comparison Across Groups in Societal Costs
timeFrame: 24 months
measure: Net Saving/Spending Comparisons Across Groups From Provider Perspective
timeFrame: 24 months
measure: Net Comparisons of Savings and Spendings Across Groups From Societal Perspective
timeFrame: 24 months
measure: Percent Days Cocaine Use
timeFrame: 3 months (approximately study days 1 - 90)
measure: Percent Days Cocaine Use
timeFrame: 6 months (approproximately study days 91 - 180)
measure: Percent Days Cocaine Use
timeFrame: 9 months (approximately study days 181 - 270)
measure: Percent Days Cocaine Use
timeFrame: 12 months (approximately study days 271 - 365)
measure: Percent Days Cocaine Use
timeFrame: 18 months (approximately study days 366 - 546)
measure: Percent Days Cocaine Use
timeFrame: 24 months (approximately study days 547 - 730)
measure: Percent Days Abstinent
timeFrame: 3 months (approximately study days 1 - 90)
measure: Percent Days Abstinent
timeFrame: 6 months (approximately study days 91 - 180)
measure: Percent Days Abstinent
timeFrame: 9 months (approximately study days 181 - 270)
measure: Percent Days Abstinent
timeFrame: 12 months (approximately study days 271 - 365)
measure: Percent Days Abstinent
timeFrame: 18 months (approximately days 366 - 546)
measure: Percent Days Abstinent
timeFrame: 24 months (approximately study days 547 - 730)
Secondary outcomes:
measure: Participation in Protocol
timeFrame: 24 months
measure: HIV Sex Risk Score
timeFrame: 12 months
measure: HIV Sex Risk Score
timeFrame: 24 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Presbyterian Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: NorthEast Treatment Centers
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: James R McKay, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.