Cocaine DependencePhase 2NCT01153464
Effectiveness of Extended Treatment for Drug Dependence (ETDD) in the City Study
A Phase 2 study testing Recovery Support Counseling in people with Cocaine Dependence, run by University of Pennsylvania at 1 site in United States.
Trial summary
This protocol (a supplement to 805466) is to test whether our telephone continuing care model can be implemented successfully by "real world" publicly funded programs. Participants will be recruited from Philadelphia's Department of Behavioral Health - run drug programs. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cocaine Dependence
- What is being tested?
- Recovery Support Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Sep 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- (1) qualify for a DSM-IV diagnosis of cocaine dependence, with cocaine use in the 6 months prior to entrance into the City of Philadelphia Department of Behavioral Health facilities or controlled environment;
- (2) 18 to 75 years of age;
- (3) no current psychotic disorder (as assessed with the psychotic screen from the SCID) or evidence of dementia severe enough to prevent participation in outpatient treatment;
- (4) no acute medical problem requiring immediate inpatient treatment;
- (5) no current participation in methadone or other modes of Drug and Alcohol treatment, other than an Intensive Outpatient Program;
- (6) willingness to be randomized and participate in research.
- (7) Finally, because of study follow-up requirements, subjects will be able to provide the name, verified telephone number, and address of at least two contacts who can provide locating information on the patient during follow-up. We will include patients with dependence on other substances, provided that they are cocaine dependent and meet other inclusion criteria.
Who cannot join
- Current dependence on opiates is an exclusion as those participants may be better served as part of a methadone program rather than a telephone based therapy protocol. Also, if patients are court-ordered to treatment, or otherwise considered prisoners, they will not be included in the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Effectiveness of Extended Treatment for Drug Dependence - City Supplement
This protocol (a supplement to 805466) is to test whether our telephone continuing care model can be implemented successfully by "real world" publicly funded programs. Participants will be recruited from Philadelphia's Department of Behavioral Health - run drug programs. The investigators will train city telephone care managers to deliver our telephone continuing care intervention to patients in this program. The investigators will randomize 200 to receive this intervention or usual care and follow them for 12 months.
- Conditions
- Cocaine Dependence
- Being tested
- Recovery Support Counseling
- 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.
Recovery Support CounselingBehavioural
Telephone based recovery support provided by paraprofessionals at the City of Philadelphia's Behavioral Health Department. Calls are once weekly for 8 weeks, then step down to every other week for the remainder of the year of study participation. Call frequency can be increased as a result of a rise in risk factor/protective factor ratio.
| Study group | Role | What they receive |
|---|---|---|
| Treatment As Usual | No intervention | In this arm, participants are not provided any intervention through the study, they are just followed for research purposes at 3m, 6m, 9m, and 12m post baseline as the comparison group. |
| Recovery Support Counseling | Experimental | This group is eligible to receive the telephone based recovery support counseling from paraprofessionals based out of the City of Philadelphia's Department of Behavioral Health. Receives: Behavioral: Recovery Support Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time Line Follow Back
abstinence from drug and alcohol use within each 3 month period of the follow-up (as indicated by the TLFB)
Measured: 3 month
Time Line Follow Back
abstinence from drug and alcohol use within each 3 month period of the follow-up (as indicated by the TLFB)
Measured: 6 month
Time Line Follow Back
abstinence from drug and alcohol use within each 3 month period of the follow-up (as indicated by the TLFB)
Measured: 9 month
Time Line Follow Back
abstinence from drug and alcohol use within each 3 month period of the follow-up (as indicated by the TLFB)
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2010 (estimated)
- Study startOct 2009
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01153464
- Sponsor's protocol ID
- 810106
- Status last verified
- Mar 2017
- First submitted
- 24 Jun 2010
- Last updated
- 30 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Extended Treatment for Drug Dependence - City Supplement
- ClinicalTrials.gov ID
- NCT01153464
- Acronym / sponsor ID
- 810106
- Conditions
- Cocaine Dependence
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 30 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This protocol (a supplement to 805466) is to test whether our telephone continuing care model can be implemented successfully by "real world" publicly funded programs. Participants will be recruited from Philadelphia's Department of Behavioral Health - run drug programs. The investigators will train city telephone care managers to deliver our telephone continuing care intervention to patients in this program. The investigators will randomize 200 to receive this intervention or usual care and follow them for 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment As Usual | No intervention | –In this arm, participants are not provided any intervention through the study, they are just followed for research purposes at 3m, 6m, 9m, and 12m post baseline as the comparison group. |
| Recovery Support Counseling | Experimental | Behavioral: Recovery Support CounselingThis group is eligible to receive the telephone based recovery support counseling from paraprofessionals based out of the City of Philadelphia's Department of Behavioral Health. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- (1) qualify for a DSM-IV diagnosis of cocaine dependence, with cocaine use in the 6 months prior to entrance into the City of Philadelphia Department of Behavioral Health facilities or controlled environment;
- (2) 18 to 75 years of age;
- (3) no current psychotic disorder (as assessed with the psychotic screen from the SCID) or evidence of dementia severe enough to prevent participation in outpatient treatment;
- (4) no acute medical problem requiring immediate inpatient treatment;
- (5) no current participation in methadone or other modes of Drug and Alcohol treatment, other than an Intensive Outpatient Program;
Key exclusion criteria (1 listed)
- Current dependence on opiates is an exclusion as those participants may be better served as part of a methadone program rather than a telephone based therapy protocol. Also, if patients are court-ordered to treatment, or otherwise considered prisoners, they will not be included in the study.
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 |
|---|---|---|
| Recovery Support CounselingTelephone based recovery support provided by paraprofessionals at the City of Philadelphia's Behavioral Health Department. Calls are once weekly for 8 weeks, then step down to every other week for the remainder of the year of study participation. Call frequency can be increased as a result of a rise in risk factor/protective factor ratio. | Behavioural | Recovery Support Counseling |
Primary outcome
Time Line Follow Back
Time frame: 3 month
abstinence from drug and alcohol use within each 3 month period of the follow-up (as indicated by the TLFB)
Time Line Follow Back
Time frame: 6 month
abstinence from drug and alcohol use within each 3 month period of the follow-up (as indicated by the TLFB)
Time Line Follow Back
Time frame: 9 month
abstinence from drug and alcohol use within each 3 month period of the follow-up (as indicated by the TLFB)
Time Line Follow Back
Time frame: 12 month
abstinence from drug and alcohol use within each 3 month period of the follow-up (as indicated by the TLFB)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Recovery Support Counseling in people with Cocaine Dependence, run by University of Pennsylvania at 1 site in United States.
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 7 inclusion and 1 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 30 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Time Line Follow Back (time frame: 3 month). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Mar 2017.