Our work during the past ten years has established the efficacy of cognitive-behavioral therapy (CBT), alone and in combination with medication, for cocaine dependence. It is now important to explore the extent to which outcomes for CBT can be maximized. Emerging evidence suggests that acquisition of skills through practice of coping skills outside of sessions facilitates better outcomes in CBT; thus, strategies that facilitate completion of homework tasks are likely to improve outcomes in CBT. In addition, disulfiram has been demonstrated through a recent series of randomized double blind controlled trials to significantly reduce cocaine use, particularly in combination with CBT. However, lack of adherence can undercut the effectiveness of disulfiram. Contingency management (CM) approaches are highly effective in their own right as behavioral interventions for cocaine use disorders and can be used to promote other target behaviors, such as compliance with other therapies. CM has not yet been explored as a strategy to enhance outcomes by promoting adherence to CBT or to disulfiram treatment of cocaine dependence.
Specific aims for this Stage II trial are: First, to conduct a 12 week randomized clinical trial, using a 2x2 factorial model, with 160 cocaine dependent outpatients, that will evaluate the efficacy of CBT in combination with either: (1)placebo, (2) disulfiram, (3)placebo plus CM, or (4) disulfiram plus CM. Second, to evaluate the long-term durability and/or delayed emergence of treatment effects after termination of the study treatments through a one-year follow-up. The primary outcomes will be self-reported cocaine use (days of abstinence by week), and results of thrice weekly urine toxicology screens. Compliance with disulfiram treatment will be monitored by the riboflavin tracer procedure. Behavioral treatments will be manual-guided and monitored for therapist skill and adherence to manual guidelines. Follow-ups at 1, 3, 6, 9 and 12 months after cessation of study treatment will assess the durability and/or delayed emergence of treatment effects. Variables assessing theoretical mechanisms of action will be assessed monthly during treatment.

Agency
National Institute of Health (NIH)
Institute
National Institute on Drug Abuse (NIDA)
Type
Research Project (R01)
Project #
5R01DA019078-04
Application #
7391820
Study Section
Special Emphasis Panel (ZDA1-MXG-S (07))
Program Officer
Onken, Lisa
Project Start
2005-04-25
Project End
2010-03-31
Budget Start
2008-04-01
Budget End
2009-03-31
Support Year
4
Fiscal Year
2008
Total Cost
$328,777
Indirect Cost
Name
Yale University
Department
Psychiatry
Type
Schools of Medicine
DUNS #
043207562
City
New Haven
State
CT
Country
United States
Zip Code
06520
DeVito, Elise E; Dong, Guangheng; Kober, Hedy et al. (2017) Functional neural changes following behavioral therapies and disulfiram for cocaine dependence. Psychol Addict Behav 31:534-547
Carroll, Kathleen M; Nich, Charla; Petry, Nancy M et al. (2016) A randomized factorial trial of disulfiram and contingency management to enhance cognitive behavioral therapy for cocaine dependence. Drug Alcohol Depend 160:135-42
Balodis, Iris M; Kober, Hedy; Worhunsky, Patrick D et al. (2016) Neurofunctional Reward Processing Changes in Cocaine Dependence During Recovery. Neuropsychopharmacology 41:2112-21
Carroll, Kathleen M; Kiluk, Brian D; Nich, Charla et al. (2014) Toward empirical identification of a clinically meaningful indicator of treatment outcome: features of candidate indicators and evaluation of sensitivity to treatment effects and relationship to one year follow up cocaine use outcomes. Drug Alcohol Depend 137:3-19
Carroll, Kathleen M (2012) Dissemination of evidence-based practices: how far we've come, and how much further we've got to go. Addiction 107:1031-3
Carroll, Kathleen M; Nich, Charla; Lapaglia, Donna M et al. (2012) Combining cognitive behavioral therapy and contingency management to enhance their effects in treating cannabis dependence: less can be more, more or less. Addiction 107:1650-9
Oliveto, Alison; Poling, James; Mancino, Michael J et al. (2011) Randomized, double blind, placebo-controlled trial of disulfiram for the treatment of cocaine dependence in methadone-stabilized patients. Drug Alcohol Depend 113:184-91
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Carroll, Kathleen M; Ball, Samuel A; Martino, Steve et al. (2009) Enduring effects of a computer-assisted training program for cognitive behavioral therapy: a 6-month follow-up of CBT4CBT. Drug Alcohol Depend 100:178-81
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