A SMART Design for Attendance-based Prize CM

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by University of Connecticut Health Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Connecticut Health Center
ClinicalTrials.gov Identifier:
NCT00840151
First received: February 7, 2009
Last updated: February 24, 2014
Last verified: July 2013
  Purpose

The purpose of this study is to compare different forms of treatment for substance abuse. This study will involve a type of treatment called contingency management, in which patients receive incentives (prizes) for attending outpatient treatment. This study will compare contingency management to standard treatment that does not involve incentives. This study will also compare contingency management treatment that lasts 6 weeks to contingency management that lasts 12 weeks. Finally, this study will compare contingency management treatment delivered at the beginning of outpatient treatment to contingency management treatment delivered later during outpatient treatment. The investigators hypothesize that (1) a 12-week attendance-based contingency management intervention will improve retention and enhance drug abstinence versus standard treatment, (2) initial short-term exposure to attendance-based contingency management (in weeks 1-6 only) will improve substance abuse treatment outcomes compared to standard treatment alone, and (3) contingency management in weeks 7-12 will be particularly useful for those with sporadic attendance or continued drug use during initial stages of treatment.


Condition Intervention Phase
Substance Abuse
Behavioral: contingency management
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A SMART Design for Attendance-based Prize CM

Further study details as provided by University of Connecticut Health Center:

Primary Outcome Measures:
  • longest duration of negative drug and alcohol samples submitted [ Time Frame: throughout active phase and at each follow-up assessment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • proportions of samples testing negative for drugs and alcohol [ Time Frame: during active phase and at each follow-up assessment ] [ Designated as safety issue: No ]
  • psychosocial functioning and HIV risk behaviors [ Time Frame: baseline, active phase and at each follow-up assessment ] [ Designated as safety issue: No ]

Estimated Enrollment: 360
Study Start Date: January 2009
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Treatment Group A
Individuals randomized to Treatment Group A will receive standard treatment for study weeks 1-6.
Experimental: Treatment Group B
Individuals randomized to Treatment Group B will receive contingency management plus standard treatment for study weeks 1-6.
Behavioral: contingency management
Participants randomized to a contingency management treatment condition can earn the chance to win prizes for attending substance abuse treatment.
No Intervention: Aftercare Group A
All participants will be re-randomized after study week 6. Those participants assigned to Aftercare Group A will receive standard treatment for study weeks 7-12.
Experimental: Aftercare Group B
All participants will be re-randomized after study week 6. Those participants assigned to Aftercare Group B will receive contingency management treatment plus standard treatment for weeks 7-12.
Behavioral: contingency management
Participants randomized to a contingency management treatment condition can earn the chance to win prizes for attending substance abuse treatment.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age > 18 years
  • current DSM-IV diagnosis of cocaine abuse or dependence or recent cocaine use (self-reported use in past 30 days or positive urine toxicology screen)
  • willing to sign informed consent and able to pass an informed consent quiz

Exclusion Criteria:

  • serious, uncontrolled psychiatric illness (e.g., acute schizophrenia, bipolar disorder, severe or psychotic major depression, or suicide risk) on the basis of history or medical examination
  • in recovery from pathological gambling (meet DSM-IV criteria for lifetime pathological gambling and are actively trying to refrain from gambling)
  • do not speak English (all treatment is provided in English at these clinics)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00840151

Contacts
Contact: Ellen M Ciesielski, B.A. 860-679-4556 eciesielski@uchc.edu

Locations
United States, Connecticut
University of Connecticut Health Center Recruiting
Farmington, Connecticut, United States, 06030
Principal Investigator: Nancy M Petry, Ph.D.         
Sponsors and Collaborators
University of Connecticut Health Center
Investigators
Principal Investigator: Nancy M Petry, Ph.D. University of Connecticut Health Center
  More Information

No publications provided

Responsible Party: University of Connecticut Health Center
ClinicalTrials.gov Identifier: NCT00840151     History of Changes
Other Study ID Numbers: 09-053-2, P50DA009241-16
Study First Received: February 7, 2009
Last Updated: February 24, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Connecticut Health Center:
Substance Abuse
Contingency Management

ClinicalTrials.gov processed this record on September 22, 2014