NCT00350649

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
205

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Dec 2004

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2004

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

July 7, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 11, 2006

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

September 27, 2011

Status Verified

September 1, 2011

Enrollment Period

5.8 years

First QC Date

July 7, 2006

Last Update Submit

September 26, 2011

Conditions

Keywords

behavior modificationcognitive behavioral therapycombination therapydrug abuse therapydrug additionhuman therapy evaluationpsychotherapyclinical trial phase IIcopingdrug and alcohol abstinencelongitudinal human studyoutcomes researchoutpatient carepsychological reinforcementtherapy compliancebehavior and social research taghuman subjectsneuropsychological testpatient oriented research

Outcome Measures

Primary Outcomes (1)

  • Self reported marijuana use (days of abstinence by week) and results of urine toxicology screens

    12 weeks

Secondary Outcomes (1)

  • Economic analysis with use of PACC-SAT

    12 weeks

Study Arms (4)

1

EXPERIMENTAL

manualized delivery of CBT by trained clinicians

Behavioral: Standard CBT

2

ACTIVE COMPARATOR

CBT with Contingency Management reinforcement for attendance and completing homework (CBT+CM/adherence)

Behavioral: CBT+CM/adherence

3

EXPERIMENTAL

Contingency Management for abstinence alone (CM/abstinence)

Behavioral: CM/abstinence

4

ACTIVE COMPARATOR

Contingency Management integrated with CBT (CM/abstinence+CBT)

Behavioral: CM/abstinence+CBT

Interventions

Standard CBTBEHAVIORAL

Manualized delivery of CBT by trained clinicians

1

CBT and Clinical Management for attendance and completing homework

2
CM/abstinenceBEHAVIORAL

Contingency Management

3

Contingency Management for abstinence in addition to manualized CBT delivered by a trained clinician

4

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • unable to commit to 1 year follow up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ASAP/1 Long Wharf

New Haven, Connecticut, 06512, United States

Location

MeSH Terms

Conditions

Marijuana AbuseAlcohol AbstinencePatient ComplianceBehavior

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental DisordersDrinking BehaviorPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth Behavior

Study Officials

  • Kathleen Carroll, PhD

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 7, 2006

First Posted

July 11, 2006

Study Start

December 1, 2004

Primary Completion

September 1, 2010

Study Completion

September 1, 2010

Last Updated

September 27, 2011

Record last verified: 2011-09

Locations