NCT01633138

Brief Summary

The purpose of this study is to investigate whether monetary reinforcement for performance will enhance the effects of cognitive remediation therapy for substance users seeking treatment at an outpatient facility.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2012

Typical duration for not_applicable

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

First Submitted

Initial submission to the registry

June 27, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 4, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2012

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

March 9, 2020

Status Verified

March 1, 2020

Enrollment Period

2.2 years

First QC Date

June 27, 2012

Last Update Submit

March 4, 2020

Conditions

Keywords

cognitive remediation therapysubstance abuse treatment

Outcome Measures

Primary Outcomes (1)

  • Improvement in performance scores on computerized cognitive remediation tasks

    Performance scores on various computerized cognitive remediation tasks will be measured repeatedly during the 4 week study. These scores include "time to completion", "number of errors", "number of words correctly recalled", and "percentage of task completed"

    4 weeks

Secondary Outcomes (1)

  • Improved cognitive function on neuropsychological tests

    4 weeks

Study Arms (2)

CRT-S

ACTIVE COMPARATOR

Cognitive Remediation Therapy - Standard

Behavioral: Cognitive Remediation Therapy - Standard

CRT-CM

EXPERIMENTAL

Cognitive Remediation Therapy plus Contingency Management

Behavioral: Cognitive Remediation Therapy plus Contingency Management

Interventions

Computerized cognitive remediation therapy provided three times per week for four weeks

CRT-S

Standard cognitive remediation therapy plus monetary incentives based on performance provided three times per week for four weeks.

CRT-CM

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • to 60 years old
  • Primary Alcohol and/or Cocaine Abuse/Dependence Diagnosis
  • Abstinence from all drugs/alcohol for 30 days
  • Mild cognitive impairment
  • Sufficiently stable and plan to commit to 4 weeks of outpatient treatment
  • Fluent in English and 6th grade reading ability

You may not qualify if:

  • Severe cognitive impairment indicative of dementia
  • Untreated bipolar or psychotic disorder
  • Have current legal case pending such that incarceration during 4-week study is likely

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Substance Abuse Treatment Unit

New Haven, Connecticut, 06511, United States

Location

MeSH Terms

Conditions

Substance-Related DisordersMental Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Study Officials

  • Brian D Kiluk, PhD

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2012

First Posted

July 4, 2012

Study Start

September 1, 2012

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

March 9, 2020

Record last verified: 2020-03

Locations