Clinical trial NCT00350649: Maximizing the Efficacy of Cognitive Behavior Therapy and Contingency Management
Official title: Maximizing the Efficacy of Cognitive Behavior Therapy and Contingency Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Marijuana Dependence
Keywords: behavior modification
cognitive behavioral therapy
combination therapy
drug abuse therapy
drug addition
human therapy evaluation
psychotherapy
clinical trial phase II
coping
drug and alcohol abstinence
longitudinal human study
outcomes research
outpatient care
psychological reinforcement
therapy compliance
behavior and social research tag
human subjects
neuropsychological test
patient oriented research
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2006-07-11
Enrollment: 205
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Cognitive-behavioral coping skills therapy (CBT) is a widely used and recognized treatment that has been empirically validated for a range of substance use disorders, often with emergent effects and continuing improvement even after treatment ends. Treatment retention and compliance are associated with enhanced treatment outcomes in CBT. Contingency management (CM) also has very strong support and is associated with rapid, robust effects on targeted outcomes. Despite their many strengths, neither CBT nor CM is universally effective. It is now essential to seek strategies to maximize and extend the effectiveness of these two approaches and to better understand how these treatments exert their effects.

Detailed description: The investigators propose to evaluate targeted strategies to maximize the effectiveness of CBT and CM, respectively. To maximize the effectiveness of CBT, the investigators will evaluate the benefit of adding CM, with reinforcement for session attendance and homework completion, to standard individual CBT for outpatient marijuana abusers, in order to expose participants to more skill training and opportunities for practice of skills. To maximize the effectiveness and durability of CM, we will evaluate the benefit of integrating it with skills training, specifically designed to reduce drop off effects, in order to extend CM's benefits beyond the active treatment period. We propose to conduct a Stage II trial which will: (1) Evaluate the efficacy of four conditions for 160 marijuana dependent outpatients: (a) Standard CBT, (b) CBT with CM reinforcement for attendance and completing homework (CBT+CM/adherence), (c) CM for abstinence alone (CM/abstinence), (d) CM for abstinence integrated with CBT (CM/abstinence+CBT), and (2) Evaluate the longer-term durability and / or delayed emergence of treatment effects after termination of the study treatments through a one-year follow-up. Secondary aims will be to conduct (a) detailed process studies to evaluate whether the proposed enhancements affect proximal and distal outcomes as hypothesized and (b) economic analyses. Study treatments will last 12 weeks.

Eligibility criteria: Inclusion Criteria:

* 18-65 year old marijuana dependent
* willing to sign consent
* no use of prescribed psychotropic drugs
* willing to give three individuals as contacts
* willing to accept randomization
* read and write English (third grade level)

Exclusion Criteria:

* unable to commit to 1 year follow up

Primary outcomes:
measure: Self reported marijuana use (days of abstinence by week) and results of urine toxicology screens
timeFrame: 12 weeks
Secondary outcomes:
measure: Economic analysis with use of PACC-SAT
timeFrame: 12 weeks
Other outcomes:
Locations:
city: New Haven
country: United States
facility: ASAP/1 Long Wharf
state: Connecticut
Study officials:
affiliation: Yale University
name: Kathleen Carroll, PhD
role: PRINCIPAL_INVESTIGATOR
References: