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Maximizing the Efficacy of Cognitive Behavior Therapy and Contingency Management

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Yale University

Status and phase

Completed
Phase 2

Conditions

Marijuana Dependence

Treatments

Behavioral: CM/abstinence+CBT
Behavioral: CM/abstinence
Behavioral: CBT+CM/adherence
Behavioral: Standard CBT

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00350649
0407026913

Details and patient eligibility

About

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.

Full 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.

Enrollment

205 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

205 participants in 4 patient groups

1
Experimental group
Description:
manualized delivery of CBT by trained clinicians
Treatment:
Behavioral: Standard CBT
2
Active Comparator group
Description:
CBT with Contingency Management reinforcement for attendance and completing homework (CBT+CM/adherence)
Treatment:
Behavioral: CBT+CM/adherence
3
Experimental group
Description:
Contingency Management for abstinence alone (CM/abstinence)
Treatment:
Behavioral: CM/abstinence
4
Active Comparator group
Description:
Contingency Management integrated with CBT (CM/abstinence+CBT)
Treatment:
Behavioral: CM/abstinence+CBT

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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