This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

Effectiveness of Extended Treatments for Drug Dependence (ETDD)

This study has been completed.
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00685659
First received: May 23, 2008
Last updated: June 28, 2017
Last verified: June 2017
  Purpose
This study tests the effectiveness of two 24 month, telephone-based adaptive continuing care interventions for patients with cocaine dependence. The two interventions are predicted to produce better drug use outcomes than standard care. Furthermore, the intervention that also includes monetary incentives for continued participation is hypothesized to produce better retention and drug use outcomes than the intervention without incentives. Economic analyses will determine the cost-effectiveness and benefit-cost of the interventions relative to standard care, and to each other.

Condition Intervention
Cocaine Dependence Other: Intensive Outpatient Treatment Other: Adaptive telephone-based counseling Other: Adaptive telephone-based counseling plus incentives

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effectiveness of Extended Treatments for Drug Dependence

Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Abstinence [ Time Frame: 3 month follow up ]
    Abstinence as reported on Addiction Severity Index, Timeline Follow up, and as tested on the urine drug screen. Measure was created as such: if on ASI the participant reported no use, and on the TLFB the participant reported no use, and on the urine drug screen there was no substances detected, then the participant is considered abstinent. If there is use indicated on any one or all of those items (ASI, TLFB, UDS) then the participant is not abstinent.

  • Abstinence [ Time Frame: 6 month follow up ]
    Abstinence as reported on Addiction Severity Index, Timeline Follow up, and as tested on the urine drug screen. Measure was created as such: if on ASI the participant reported no use, and on the TLFB the participant reported no use, and on the urine drug screen there was no substances detected, then the participant is considered abstinent. If there is use indicated on any one or all of those items (ASI, TLFB, UDS) then the participant is not abstinent.

  • Abstinence [ Time Frame: 9 month follow up ]
    Abstinence as reported on Addiction Severity Index, Timeline Follow up, and as tested on the urine drug screen. Measure was created as such: if on ASI the participant reported no use, and on the TLFB the participant reported no use, and on the urine drug screen there was no substances detected, then the participant is considered abstinent. If there is use indicated on any one or all of those items (ASI, TLFB, UDS) then the participant is not abstinent.

  • Abstinence [ Time Frame: 12 month follow up ]
    Abstinence as reported on Addiction Severity Index, Timeline Follow up, and as tested on the urine drug screen. Measure was created as such: if on ASI the participant reported no use, and on the TLFB the participant reported no use, and on the urine drug screen there was no substances detected, then the participant is considered abstinent. If there is use indicated on any one or all of those items (ASI, TLFB, UDS) then the participant is not abstinent.

  • Abstinence [ Time Frame: 18 month follow up ]
    Abstinence as reported on Addiction Severity Index, Timeline Follow up, and as tested on the urine drug screen. Measure was created as such: if on ASI the participant reported no use, and on the TLFB the participant reported no use, and on the urine drug screen there was no substances detected, then the participant is considered abstinent. If there is use indicated on any one or all of those items (ASI, TLFB, UDS) then the participant is not abstinent.

  • Abstinence [ Time Frame: 24 month follow up ]
    Abstinence as reported on Addiction Severity Index, Timeline Follow up, and as tested on the urine drug screen. Measure was created as such: if on ASI the participant reported no use, and on the TLFB the participant reported no use, and on the urine drug screen there was no substances detected, then the participant is considered abstinent. If there is use indicated on any one or all of those items (ASI, TLFB, UDS) then the participant is not abstinent.

  • Cocaine Urine Toxicology [ Time Frame: 3 month follow up ]
    Positive cocaine test of urine

  • Cocaine Urine Toxicology [ Time Frame: 6 month follow up ]
    Positive cocaine test of urine

  • Cocaine Urine Toxicology [ Time Frame: 9 month follow up ]
    Positive cocaine test of urine

  • Cocaine Urine Toxicology [ Time Frame: 12 month follow up ]
    Positive cocaine test of urine

  • Cocaine Urine Toxicology [ Time Frame: 18 month follow up ]
    Positive cocaine test of urine

  • Cocaine Urine Toxicology [ Time Frame: 24 month follow up ]
    Positive cocaine test of urine

  • Comparison Across Groups in Societal Costs [ Time Frame: 24 months ]
    Total savings/spending calculated as the monetary value of days of illegal activity, days experiencing medical problems, days experiencing psychiatric problems, and days in jail captured with the ASI. Presented in 2008 dollars.

  • Net Saving/Spending Comparisons Across Groups From Provider Perspective [ Time Frame: 24 months ]
    Savings minus intervention costs. Presented in 2008 dollars.

  • Net Comparisons of Savings and Spendings Across Groups From Societal Perspective [ Time Frame: 24 months ]
    Savings minus intervention costs. Presented in 2008 dollars.

  • Percent Days Cocaine Use [ Time Frame: 3 months (approximately study days 1 - 90) ]
    Percent of days during the follow up that there was any cocaine use

  • Percent Days Cocaine Use [ Time Frame: 6 months (approproximately study days 91 - 180) ]
    Percent of days during the follow up that there was any cocaine use

  • Percent Days Cocaine Use [ Time Frame: 9 months (approximately study days 181 - 270) ]
    Percent of days during the follow up that there was any cocaine use

  • Percent Days Cocaine Use [ Time Frame: 12 months (approximately study days 271 - 365) ]
    Percent of days during the follow up that there was any cocaine use

  • Percent Days Cocaine Use [ Time Frame: 18 months (approximately study days 366 - 546) ]
    Percent of days during the follow up that there was any cocaine use

  • Percent Days Cocaine Use [ Time Frame: 24 months (approximately study days 547 - 730) ]
    Percent of days during the follow up that there was any cocaine use

  • Percent Days Abstinent [ Time Frame: 3 months (approximately study days 1 - 90) ]
    Percent of days during the follow up that participant was abstinent from Alcohol and Cocaine

  • Percent Days Abstinent [ Time Frame: 6 months (approximately study days 91 - 180) ]
    Percent of days during the follow up that participant was abstinent from Alcohol and Cocaine

  • Percent Days Abstinent [ Time Frame: 9 months (approximately study days 181 - 270) ]
    Percent of days during the follow up that participant was abstinent from Alcohol and Cocaine

  • Percent Days Abstinent [ Time Frame: 12 months (approximately study days 271 - 365) ]
    Percent of days during the follow up that participant was abstinent from Alcohol and Cocaine

  • Percent Days Abstinent [ Time Frame: 18 months (approximately days 366 - 546) ]
    Percent of days during the follow up that participant was abstinent from Alcohol and Cocaine

  • Percent Days Abstinent [ Time Frame: 24 months (approximately study days 547 - 730) ]
    Percent of days during the follow up that participant was abstinent from Alcohol and Cocaine


Secondary Outcome Measures:
  • Participation in Protocol [ Time Frame: 24 months ]
    Percent available sessions completed

  • HIV Sex Risk Score [ Time Frame: 12 months ]
    Risk score from RAB: Risk Assessment Battery. The RAB is a 41 - item self report developed to study the transmission of HIV. The Risk Assessment Battery generates a drug-risk score and a sex-risk score. For this study, the sex-risk score was used as the outcome measure of sexual behavior that is associated with HIV transmission. The sex-risk score ranges from 0 to 18, with 0 denoting no sex-risk and 18 denoting highest sex-risk. Previous research among drug using populations have found a sex-risk score mean of 6.2.

  • HIV Sex Risk Score [ Time Frame: 24 months ]
    Risk score from RAB: Risk Assessment Battery. The RAB is a 41 - item self report developed to study the transmission of HIV. The Risk Assessment Battery generates a drug-risk score and a sex-risk score. For this study, the sex-risk score was used as the outcome measure of sexual behavior that is associated with HIV transmission. The sex-risk score ranges from 0 to 18, with 0 denoting no sex-risk and 18 denoting highest sex-risk. Previous research among drug using populations have found a sex-risk score mean of 6.2.


Enrollment: 332
Study Start Date: May 2007
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: TAU only
Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long)
Other: Intensive Outpatient Treatment
9 hours of group counseling per week for 2-3 months
Experimental: TMAC only
Adaptive telephone-based counseling
Other: Adaptive telephone-based counseling
In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included
Experimental: TMAC plus
Adaptive telephone-based counseling, plus incentives
Other: Adaptive telephone-based counseling plus incentives
In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included

Detailed Description:

There is considerable evidence that treatment for drug use disorders can lead to substantial improvements in substance use and psychosocial problem severity. However, a significant percentage of patients relapse to problematic levels of substance use after primary treatment, and require additional treatment episodes. Patients are therefore frequently referred to continuing care programs to prevent relapse and decrease the probability of additional rehabilitation treatments. However, current models of continuing care may not be adequate for the long-term management of a chronic, relapsing disorder such as substance dependence. One possible approach for improving the management of drug dependence is adaptive treatment regimes, which combine low intensity monitoring and counseling when patients are doing well with stepped care protocols to increase the intensity of treatment when warranted by deteriorations in status and functioning. However, addiction management protocols may require incentives and other features to make long-term participation more appealing.

Cocaine dependent patients who have completed 2 weeks of intensive outpatient treatment (IOP) will be randomly assigned to one of the following interventions: (1) continued participation in IOP without additional intervention (TAU); (2) TAU plus an adaptive protocol that includes monitoring, feedback, and brief counseling via telephone on a tapered schedule out to 24 months, and more intensive face-to-face treatment when warranted (TMAC); or (3) TAU and the adaptive protocol, plus incentives for sustained participation (TMAC-Plus). Patients will be followed up at 3, 6, 9, 12, 18, and 24 months post intake into the study. Follow-up assessments will include measures of drug use, treatment process and potential mediating factors, psychosocial problem severity, utilization of health and social services, and costs.

The two adaptive extended interventions (TMAC and TMAC-Plus) are predicted to produce better drug use outcomes than TAU. TMAC-Plus is hypothesized to produce better retention and drug use outcomes than TMAC. Economic analyses will determine the cost-effectiveness and benefit-cost of TMAC and TMF-Plus relative to TAU, and to each other. Other analyses will test mediation hypotheses, examine potential moderator effects, and test the impact of disease management on HIV risk behaviors.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • qualify for a DSM-IV lifetime diagnosis of cocaine dependence and cocaine use in 6 months prior to treatment;
  • initial engagement in IOP, as indicated by attendance at 4 or more sessions in the first two weeks of treatment;
  • 18 to 75 years of age;
  • willingness to be randomized and participate in research.
  • metropolitan area residents;
  • able to provide the name, verified telephone number, and address of at least one contact who can provide locator information on the patient during follow-up.

Exclusion Criteria:

  • current psychotic disorder or evidence of dementia severe enough to prevent participation in outpatient treatment;
  • acute medical problem requiring immediate inpatient treatment;
  • current participation in methadone or other forms of DA treatment, other than IOP
  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: NCT00685659

Locations
United States, Pennsylvania
Presbyterian Hospital
Philadelphia, Pennsylvania, United States, 19104
NorthEast Treatment Centers
Philadelphia, Pennsylvania, United States, 19123
Sponsors and Collaborators
University of Pennsylvania
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: James R McKay, Ph.D. University of Pennsylvania
  More Information

Publications:
Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00685659     History of Changes
Other Study ID Numbers: R01DA020623 ( U.S. NIH Grant/Contract )
Study First Received: May 23, 2008
Results First Received: February 15, 2016
Last Updated: June 28, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University of Pennsylvania:
cocaine dependence
treatment
continuing care
outcomes
incentives
adaptive

Additional relevant MeSH terms:
Cocaine-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 19, 2017