Cocaine DependenceETDDNCT00685659

Effectiveness of Extended Treatments for Drug Dependence

A study testing Intensive Outpatient Treatment, Adaptive telephone-based counseling and Adaptive telephone-based counseling plus incentives in people with Cocaine Dependence, run by University of Pennsylvania at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Cocaine Dependence
What is being tested?: Intensive Outpatient Treatment, Adaptive telephone-based counseling and Adaptive telephone-based counseling plus incentives
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 332 participants
Where: 2 sitesUnited States
Study dates: May 2007to Dec 2011
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Presbyterian Hospital
Philadelphia, Pennsylvania, 19104
NorthEast Treatment Centers
Philadelphia, Pennsylvania, 19123

Other trials in United States

About this study

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.

Read the 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.

Conditions: Cocaine Dependence
Being tested: Intensive Outpatient Treatment, Adaptive telephone-based counseling, Adaptive telephone-based counseling plus incentives
Keywords: cocaine dependence, treatment, continuing care, outcomes, incentives, adaptive
Medical subject headings: Cocaine-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Intensive Outpatient TreatmentOther
9 hours of group counseling per week for 2-3 months
Adaptive telephone-based counselingOther
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 incentivesOther
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

Study groups in NCT00685659
Study group	Role	What they receive
TAU only	Active comparator	Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long) Receives: Other: Intensive Outpatient Treatment
TMAC only	Experimental	Adaptive telephone-based counseling Receives: Other: Adaptive telephone-based counseling
TMAC plus	Experimental	Adaptive telephone-based counseling, plus incentives Receives: Other: Adaptive telephone-based counseling plus incentives

What is being measured

The primary outcome is the main question the study is designed to answer.

Abstinence
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.
Measured: 3 month follow up
Abstinence
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.
Measured: 6 month follow up
Abstinence
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.
Measured: 9 month follow up
Abstinence
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.
Measured: 12 month follow up
Abstinence
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.
Measured: 18 month follow up
Abstinence
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.
Measured: 24 month follow up
Cocaine Urine Toxicology
Positive cocaine test of urine
Measured: 3 month follow up
Cocaine Urine Toxicology
Positive cocaine test of urine
Measured: 6 month follow up
Cocaine Urine Toxicology
Positive cocaine test of urine
Measured: 9 month follow up
Cocaine Urine Toxicology
Positive cocaine test of urine
Measured: 12 month follow up
Cocaine Urine Toxicology
Positive cocaine test of urine
Measured: 18 month follow up
Cocaine Urine Toxicology
Positive cocaine test of urine
Measured: 24 month follow up
Comparison Across Groups in Societal Costs
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.
Measured: 24 months
Net Saving/Spending Comparisons Across Groups From Provider Perspective
Savings minus intervention costs. Presented in 2008 dollars.
Measured: 24 months
Net Comparisons of Savings and Spendings Across Groups From Societal Perspective
Savings minus intervention costs. Presented in 2008 dollars.
Measured: 24 months
Percent Days Cocaine Use
Percent of days during the follow up that there was any cocaine use
Measured: 3 months (approximately study days 1 - 90)
Percent Days Cocaine Use
Percent of days during the follow up that there was any cocaine use
Measured: 6 months (approproximately study days 91 - 180)
Percent Days Cocaine Use
Percent of days during the follow up that there was any cocaine use
Measured: 9 months (approximately study days 181 - 270)
Percent Days Cocaine Use
Percent of days during the follow up that there was any cocaine use
Measured: 12 months (approximately study days 271 - 365)
Percent Days Cocaine Use
Percent of days during the follow up that there was any cocaine use
Measured: 18 months (approximately study days 366 - 546)
Percent Days Cocaine Use
Percent of days during the follow up that there was any cocaine use
Measured: 24 months (approximately study days 547 - 730)
Percent Days Abstinent
Percent of days during the follow up that participant was abstinent from Alcohol and Cocaine
Measured: 3 months (approximately study days 1 - 90)
Percent Days Abstinent
Percent of days during the follow up that participant was abstinent from Alcohol and Cocaine
Measured: 6 months (approximately study days 91 - 180)
Percent Days Abstinent
Percent of days during the follow up that participant was abstinent from Alcohol and Cocaine
Measured: 9 months (approximately study days 181 - 270)
Percent Days Abstinent
Percent of days during the follow up that participant was abstinent from Alcohol and Cocaine
Measured: 12 months (approximately study days 271 - 365)
Percent Days Abstinent
Percent of days during the follow up that participant was abstinent from Alcohol and Cocaine
Measured: 18 months (approximately days 366 - 546)
Percent Days Abstinent
Percent of days during the follow up that participant was abstinent from Alcohol and Cocaine
Measured: 24 months (approximately study days 547 - 730)

Secondary outcomes (3)

Participation in Protocol
Percent available sessions completed
Measured: 24 months
HIV Sex Risk Score
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.
Measured: 12 months
HIV Sex Risk Score
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.
Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2007Dec 2011

First posted28 May 2008 (estimated)
Study startMay 2007
Primary completionDec 2011
Study completionDec 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (6)Papers the sponsor has linked to this study.
Other trials for Cocaine DependenceStudies of the same condition, open and under way.
More trials run by University of PennsylvaniaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 332 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00685659
Sponsor's protocol ID: R01DA020623
Other IDs: R01DA020623
Acronym: ETDD
Status last verified: Jun 2017
First submitted: 23 May 2008
Last updated: 7 Aug 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

McKay JR, Van Horn DH, Lynch KG, Ivey M, Cary MS, Drapkin ML, Coviello DM, Plebani JG. An adaptive approach for identifying cocaine dependent patients who benefit from extended continuing care. J Consult Clin Psychol. 2013 Dec;81(6):1063-73. doi: 10.1037/a0034265. Epub 2013 Sep 16.
PubMed 24041231
McKay JR, Van Horn DH, Lynch KG, Ivey M, Cary MS, Drapkin M, Coviello D. Who benefits from extended continuing care for cocaine dependence? Addict Behav. 2014 Mar;39(3):660-8. doi: 10.1016/j.addbeh.2013.11.019. Epub 2013 Dec 1.
PubMed 24355401
McKay JR, Van Horn D, Rennert L, Drapkin M, Ivey M, Koppenhaver J. Factors in sustained recovery from cocaine dependence. J Subst Abuse Treat. 2013 Aug;45(2):163-72. doi: 10.1016/j.jsat.2013.02.007. Epub 2013 Apr 2.
PubMed 23561331
Van Horn DH, Drapkin M, Ivey M, Thomas T, Domis SW, Abdalla O, Herd D, McKay JR. Voucher incentives increase treatment participation in telephone-based continuing care for cocaine dependence. Drug Alcohol Depend. 2011 Apr 1;114(2-3):225-8. doi: 10.1016/j.drugalcdep.2010.09.007. Epub 2010 Nov 1.
PubMed 21041041
Wimberly AS, Ivey M, Rennert L, McKay JR. Effect of Continuing Care for Cocaine Dependence on HIV Sex-Risk Behaviors. AIDS Behav. 2017 Apr;21(4):1082-1090. doi: 10.1007/s10461-016-1434-6.
PubMed 27224980
McCollister K, Yang X, McKay JR. Cost-effectiveness analysis of a continuing care intervention for cocaine-dependent adults. Drug Alcohol Depend. 2016 Jan 1;158:38-44. doi: 10.1016/j.drugalcdep.2015.10.032. Epub 2015 Nov 12.
PubMed 26621551

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Cocaine Dependence trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effectiveness of Extended Treatments for Drug Dependence
ClinicalTrials.gov ID: NCT00685659
Acronym / sponsor ID: ETDD / R01DA020623
Conditions: Cocaine Dependence
Keywords: cocaine dependence, treatment, continuing care, outcomes, incentives, adaptive
Study type: Interventional
Recruitment status: Completed
Enrolment: 332 participants (actual)
Lead sponsor: University of PennsylvaniaUniversity, hospital or other
Collaborators: National Institute on Drug Abuse (NIDA)
Study start: May 2007
Primary completion: Dec 2011 (actual)
Study completion: Dec 2011 (actual)
First posted: 28 May 2008 (estimated)
Results: Posted 14 Dec 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
TAU only	Active comparator	Other: Intensive Outpatient TreatmentControl condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long)
TMAC only	Experimental	Other: Adaptive telephone-based counselingAdaptive telephone-based counseling
TMAC plus	Experimental	Other: Adaptive telephone-based counseling plus incentivesAdaptive telephone-based counseling, plus incentives

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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;

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Intensive Outpatient Treatment9 hours of group counseling per week for 2-3 months	Other	TAU only
Adaptive telephone-based counselingIn 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	Other	TMAC only
Adaptive telephone-based counseling plus incentivesIn 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	Other	TMAC plus

Primary outcome

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

3 secondary outcomes

Participation in Protocol
Time frame: 24 months
HIV Sex Risk Score
Time frame: 12 months
HIV Sex Risk Score
Time frame: 24 months

Results and safety

Results posted to the registry on 14 Dec 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment as Usual	108	77
TMAC	106	81
TMAC Plus	107	92

Primary outcome: Abstinence

Time frame: 3 month follow up. Number. Unit: participants

Measure	Treatment as Usual n = 96	TMAC n = 97	TMAC Plus n = 96
Value	45	57	45

Population analysed: The N analyzed represents that number of people we reached for three month follow up evaluation.

Primary outcome: Abstinence

Time frame: 6 month follow up. Number. Unit: participants

Measure	Treatment as Usual n = 95	TMAC n = 95	TMAC Plus n = 95
Value	43	44	42

Population analysed: The N analyzed represents that number of participants we reached for 6 month follow up evaluation.

Primary outcome: Abstinence

Time frame: 9 month follow up. Number. Unit: participants

Measure	Treatment as Usual n = 91	TMAC n = 91	TMAC Plus n = 91
Value	43	44	39

Population analysed: The N analyzed represents the number of participants we were able to reach for the 9 month follow up evaluation.

Primary outcome: Abstinence

Time frame: 12 month follow up. Number. Unit: participants

Measure	Treatment as Usual n = 89	TMAC n = 90	TMAC Plus n = 90
Value	33	39	42

Population analysed: The N analyzed represents the number of participants we were able to reach at the 12 month follow up for evaluation.

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment as Usual	0 of 108 (0%)	0 of 108 (0%)	2 of 108
TMAC	0 of 106 (0%)	0 of 106 (0%)	1 of 106
TMAC Plus	0 of 107 (0%)	0 of 107 (0%)	1 of 107

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 24041231McKay JR, Van Horn DH, Lynch KG, Ivey M, Cary MS, Drapkin ML, Coviello DM, Plebani JG. An adaptive approach for identifying cocaine dependent patients who benefit from extended continuing care. J Consult Clin Psychol. 2013 Dec;81(6):1063-73. doi: 10.1037/a0034265. Epub 2013 Sep 16.
Results publication: PubMed 24355401McKay JR, Van Horn DH, Lynch KG, Ivey M, Cary MS, Drapkin M, Coviello D. Who benefits from extended continuing care for cocaine dependence? Addict Behav. 2014 Mar;39(3):660-8. doi: 10.1016/j.addbeh.2013.11.019. Epub 2013 Dec 1.
Results publication: PubMed 23561331McKay JR, Van Horn D, Rennert L, Drapkin M, Ivey M, Koppenhaver J. Factors in sustained recovery from cocaine dependence. J Subst Abuse Treat. 2013 Aug;45(2):163-72. doi: 10.1016/j.jsat.2013.02.007. Epub 2013 Apr 2.
Results publication: PubMed 21041041Van Horn DH, Drapkin M, Ivey M, Thomas T, Domis SW, Abdalla O, Herd D, McKay JR. Voucher incentives increase treatment participation in telephone-based continuing care for cocaine dependence. Drug Alcohol Depend. 2011 Apr 1;114(2-3):225-8. doi: 10.1016/j.drugalcdep.2010.09.007. Epub 2010 Nov 1.
Results publication: PubMed 27224980Wimberly AS, Ivey M, Rennert L, McKay JR. Effect of Continuing Care for Cocaine Dependence on HIV Sex-Risk Behaviors. AIDS Behav. 2017 Apr;21(4):1082-1090. doi: 10.1007/s10461-016-1434-6.
Results publication: PubMed 26621551McCollister K, Yang X, McKay JR. Cost-effectiveness analysis of a continuing care intervention for cocaine-dependent adults. Drug Alcohol Depend. 2016 Jan 1;158:38-44. doi: 10.1016/j.drugalcdep.2015.10.032. Epub 2015 Nov 12.
Individual participant dataSharing planned: No

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Cocaine Dependence, in Remission

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

James R McKay, Ph.D. principal investigator

University of Pennsylvania

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Dec 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Abstinence (time frame: 3 month follow up). The study lists 27 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00685659, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2017.