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Completed

NCT Number: NCT00685659

Effectiveness of Extended Treatments for Drug Dependence

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.

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Key information

Conditions

Cocaine Dependence Chemically-Induced Disorders Cocaine-Related Disorders Mental Disorders Substance-Related Disorders

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NorthEast Treatment Centers, Philadelphia, Pennsylvania, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intensive Outpatient Treatment

Other

9 hours of group counseling per week for 2-3 months

Adaptive telephone-based counseling

Other

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

Adaptive telephone-based counseling plus incentives

Other

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. Cocaine Urine Toxicology

    Time frame: 3 month follow up

    Positive cocaine test of urine

  8. Cocaine Urine Toxicology

    Time frame: 6 month follow up

    Positive cocaine test of urine

  9. Cocaine Urine Toxicology

    Time frame: 9 month follow up

    Positive cocaine test of urine

  10. Cocaine Urine Toxicology

    Time frame: 12 month follow up

    Positive cocaine test of urine

  11. Cocaine Urine Toxicology

    Time frame: 18 month follow up

    Positive cocaine test of urine

  12. Cocaine Urine Toxicology

    Time frame: 24 month follow up

    Positive cocaine test of urine

  13. 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.

  14. Net Saving/Spending Comparisons Across Groups From Provider Perspective

    Time frame: 24 months

    Savings minus intervention costs. Presented in 2008 dollars.

  15. Net Comparisons of Savings and Spendings Across Groups From Societal Perspective

    Time frame: 24 months

    Savings minus intervention costs. Presented in 2008 dollars.

  16. 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

  17. 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

  18. 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

  19. 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

  20. 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

  21. 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

  22. 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

  23. 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

  24. 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

  25. 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

  26. 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

  27. 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 outcomes

  1. Participation in Protocol

    Time frame: 24 months

    Percent available sessions completed

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Acronym: ETDD

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
May 28, 2008
Registry last updated
Aug 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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