Substance Use DisordersPhase 2/3NCT01032135
Adaptive Treatment for Alcohol and Cocaine Dependence
A Phase 2/3 study testing Motivational Interviewing, Telephone counseling and Cognitive Behavioral Therapy (CBT) Counseling in people with Substance Use Disorders, run by University of Pennsylvania at 3 sites in United States.
Trial summary
1. Primary objective #1: Determine the relative effectiveness of MI-IOP and MI-PC in the full study sample with regard to treatment engagement over weeks 1-12 and cocaine/alcohol use over weeks 1-24. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Substance Use Disorders
- What is being tested?
- Motivational Interviewing, Telephone counseling and Cognitive Behavioral Therapy (CBT) Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 3 sitesUnited States
- Study dates
- Oct 2008to Dec 2013
- Phase
- Phase 2/3
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- meet DSM-IV criteria for lifetime cocaine or alcohol dependence and have used cocaine or alcohol in the prior 6 months;
- be > 18 years of age;
- be judged clinically appropriate for IOP (e.g., no current psychotic disorder or evidence of severe dementia, and no acute medical problem requiring inpatient treatment;
- have no regular IV heroin use during the past year;
- have access to a telephone;
- be willing to be randomized and participate in research; and
Show all 9Show fewer
- no current participation in methadone or other forms of DA treatment, other than IOP. Finally, because of study follow-up requirements, subjects will
- be required to be metropolitan area residents, and
- be able to provide the name, verified telephone number, and address of at least two contacts who can provide locator 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
- have a current psychotic disorder (as assessed with the psychotic screen from the MINI) or evidence of dementia severe enough to prevent participation in outpatient treatment;
- have acute medical problem requiring immediate inpatient treatment; or
- are currently participating in methadone or other forms of DA treatment, other than IOP.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Presbyterian Medical Center
Philadelphia, Pennsylvania, 19104
VAMC
Philadelphia, Pennsylvania, 19104
NorthEast Treatment Center
Philadelphia, Pennsylvania, 19123
About this study
- Primary objective #1: Determine the relative effectiveness of MI-IOP and MI-PC in the full study sample with regard to treatment engagement over weeks 1-12 and cocaine/alcohol use over weeks 1-24.
- Hypothesis 1: An intervention that explores several possible treatment options with the patient and provides the chosen option (e.g., MI-PC) will produce higher rates of treatment engagement than an intervention focused on engagement in IOP only (e.g., MI-IOP).
- Hypothesis 2: An intervention that explores several possible treatment options with the patient and provides the chosen option (e.g., MI-PC) will produce better cocaine/alcohol use outcomes than an intervention focused on engagement in IOP only (MI-IOP).
- Secondary analysis 1: Among the Non-engaged patients, determine rates of selection of each of the three options in MI-PC, retention rates within each option, and cocaine/alcohol use outcomes in each option.
- Secondary analysis 2: Among the Engaged patients, determine rates of selection of each of the three options in MI-PC, retention rates within each option, and cocaine/alcohol use outcomes in each option.
Read more
- Primary objective #2: Determine whether the relative effectiveness of MI-IOP and MI-PC varies as a function of engagement group, with regard to treatment engagement over weeks 1-12 and cocaine/alcohol use outcomes over weeks 1-24.
- Hypothesis 1: The predicted main effect on retention favoring MI-PC over MI-IOP will be significantly larger among patients in the Non-engaged group than among those in the Engaged group.
- Hypothesis 2: The predicted main effect on cocaine/alcohol use outcomes favoring MI-PC over MI-IOP will be significantly larger among patients in the Non-engaged group than among those in the Engaged group.
Read the detailed description
- Secondary objective #1: Examine outcomes on three secondary measures: percent days abstinent from all substances, negative consequences of drug use, and HIV high risk behaviors.
- Hypothesis 1: Outcomes on the secondary measures will be better in MI-PC than in MI-IOP.
- Secondary objective #2: Test hypotheses concerning potential mediators of the predicted main effect favoring MI-PC over MI-IOP.
- Hypothesis 1: The predicted advantage of MI-PC over MI-IOP will be mediated by greater increases in motivation, self-efficacy, commitment to abstinence, and self-help involvement in MI-PC.
- Secondary objective #3: Test hypotheses concerning effect of additional MI intervention after initial non-engagement persists through 12 weeks.
- Hypothesis 1: A second telephone MI intervention will produce higher rates of subsequent engagement and less cocaine use than no further MI.
- Conditions
- Substance Use Disorders
- Being tested
- Motivational Interviewing, Telephone counseling, Cognitive Behavioral Therapy (CBT) Counseling, medication management, Intensive OutPatient Therapy
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational InterviewingBehavioural
Also called MI
2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.
Telephone counselingBehavioural
Also called Telephone based stepped care.
one telephone counseling session per week for 10 weeks.
Cognitive Behavioral Therapy (CBT) CounselingBehavioural
Also called CBT
One CBT session per week, for 10 weeks.
medication managementDrug
Also called MM
Prescription for naltrexone
Intensive OutPatient TherapyBehavioural
Also called IOP
Return to IOP, group therapy 3 times weekly for about three hours a day.
| Study group | Role | What they receive |
|---|---|---|
| 1-MI-IOP Engaged | Active comparator | Randomized to treatment as usual, and they attend regularly but dropped out of treatment after randomization. Receives: Behavioral: Motivational Interviewing |
| 2-MI-IOP Non-Engaged | Experimental | Randomized to treatment as usual, and do not attend. Receives: Behavioral: Motivational Interviewing; Behavioral: Telephone counseling; Behavioral: Cognitive Behavioral Therapy (CBT) Counseling; Drug: medication management; Behavioral: Intensive OutPatient Therapy |
| 3-MI-PC Engaged | Active comparator | Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization. Receives: Behavioral: Motivational Interviewing; Behavioral: Telephone counseling; Behavioral: Cognitive Behavioral Therapy (CBT) Counseling |
| 4-MI-PC Non-engaged | Experimental | Randomized to treatment choice, and do not attend treatment as usual, so the choice option is used. Receives: Behavioral: Motivational Interviewing; Behavioral: Telephone counseling; Behavioral: Cognitive Behavioral Therapy (CBT) Counseling; Drug: medication management; Behavioral: Intensive OutPatient Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Engagement
Number of treatment sessions attended
Measured: weeks 3 - 12
Treatment Engagement for Participants Engaged at 2 Weeks, But Disengage Before 8 Weeks
Number of treatment sessions attended
Measured: weeks 9 - 12
Treatment Engagement of Those Non-engaged at 2 Weeks and at 8 Weeks
Number of treatment sessions attended
Measured: weeks 9 - 12
Any Drinking Days in Previous Month
Days of any drinking in previous month, as reported on Time Line Follow Back. This is a dichotomous measure, so the means that are reported are the percentage of people who have had any days of drinking during the follow up period specified. In other words, 0.57 indicates that 57% of the sample drank in the follow up period.
Measured: Month 2 (weeks 5 - 8 post baseline)
Any Drinking Days in Previous Month
Any drinking days during previous month, as reported on Time Line Follow Back. This is a dichotomous measure, so the means that are reported are the percentage of people who have had any days of drinking during the follow up period specified. In other words, 0.57 indicates that 57% of the sample drank in the follow up period.
Measured: Month 3 (weeks 9 - 12 post baseline)
Any Drinking
Any drinking at follow up, as reported on Time Line Follow Back. This is a dichotomous measure, so the means that are reported are the percentage of people who have had any days of drinking during the follow up period specified. In other words, 0.57 indicates that 57% of the sample drank in the follow up period.
Measured: Month 4 (weeks 13 - 15 post baseline)
Any Drinking
Any drinking at follow up, as reported on Time Line Follow Back, This is a dichotomous measure, so the means that are reported are the percentage of people who have had any days of drinking during the follow up period specified. In other words, 0.57 indicates that 57% of the sample drank in the follow up period.
Measured: Month 5 (weeks 16 - 20 post baseline)
Any Drinking
Any drinking at follow up, as reported on Time Line Follow Back. This is a dichotomous measure, so the means that are reported are the percentage of people who have had any days of drinking during the follow up period specified. In other words, 0.57 indicates that 57% of the sample drank in the follow up period.
Measured: Month 6 (weeks 21 - 24 post baseline)
Percent Days Drinking
Percent days of any drinking at follow up, from Time Line Follow Back
Measured: Month 2 (weeks 5 - 8 post baseline)
Percent Days Drinking
Percent days of any drinking at follow up, from Time Line Follow Back
Measured: Month 3 (weeks 9 - 12 post baseline)
Percent Days Drinking
Percent days of any drinking at follow up, from Time Line Follow Back
Measured: Month 4 (weeks 13 - 16 post baseline)
Percent Days Drinking
Percent days of any drinking at follow up, fromTime Line Follow Back
Measured: Month 5 (weeks 17 - 20 post baseline)
Percent Days Drinking
Percent days of any drinking at follow up, from Time Line Follow Back
Measured: Month 6 (weeks 21 - 24)
Any Heavy Drinking Days
days of five or more drinks per drinking day for men, four or more drinks per drinking day for women, at follow up, from Time Line Follow Back. This is a dichotomous measure, so the means that are reported are the percentage of people who have had any days of heavy drinking during the follow up period specified. In other words, 0.57 indicates that 57% of the sample engaged in heavy drinking in the follow up period.
Measured: Month 2 (weeks 5 - 8 post baseline)
Any Heavy Drinking Days
five or more drinks per drinking day for men, four or more drinks per drinking day for women, at follow up, from Time Line Follow Back. This is a dichotomous measure, so the means that are reported are the percentage of people who have had any days of heavy drinking during the follow up period specified. In other words, 0.57 indicates that 57% of the sample engaged in heavy drinking in the follow up period.
Measured: Month 3 (weeks 9 - 12 post baseline)
Any Heavy Drinking Days
five or more drinks per drinking day for men, four or more drinks per drinking day for women at follow up, from Time Line Follow Back. This is a dichotomous measure, so the means that are reported are the percentage of people who have had any days of heavy drinking during the follow up period specified. In other words, 0.57 indicates that 57% of the sample engaged in heavy drinking in the follow up period.
Measured: Month 4 (weeks 13 - 16 post baseline)
Any Heavy Drinking Days
five or more drinks per day for men, four or more drinks per day for women, from Time Line Follow Back. This is a dichotomous measure, so the means that are reported are the percentage of people who have had any days of heavy drinking during the follow up period specified. In other words, 0.57 indicates that 57% of the sample engaged in heavy drinking in the follow up period.
Measured: Month 5 (weeks 17 to 20 post baseline)
Any Heavy Drinking Days
five or more drinks per day for men, four or more drinks per day for women, from Time Line Follow Back. This is a dichotomous measure, so the means that are reported are the percentage of people who have had any days of heavy drinking during the follow up period specified. In other words, 0.57 indicates that 57% of the sample engaged in heavy drinking in the follow up period.
Measured: Month 6 (weeks 21 - 24 post baseline)
Percent Days Heavy Drinking
Percent days heavy drinking at follow up, from Time Line Follow Back
*heavy drinking is defined as five or more drinks per day for men, four or more for women
Measured: Month 2 (weeks 5 - 8 post baseline)
Percent Days Heavy Drinking
Percent days heavy drinking at follow up, from Time Line Follow Back
- heavy drinking is defined as five or more drinks per day for men, four or more for women.
Measured: Month 3 (weeks 9 - 12 post baseline)
Percent Days Heavy Drinking
Percent days heavy drinking at follow up, from Time Line Follow Back
*heavy drinking is defined as five or more drinks per drinking day for men, four or more for women
Measured: Month 4 (weeks 13 - 16 post baseline)
Percent Days Heavy Drinking
Percent days heavy drinking at follow up, from Time Line Follow Back
- heavy drinking is defined as five or more drinks per drinking day for men, four or more for women
Measured: Month 5 ( weeks 17 - 20 post baseline)
Percent Days Heavy Drinking
Percent days heavy drinking at follow up, from Time Line Follow Back
*heavy drinking is defined as five or more drinks per drinking day for men, four or more for women
Measured: Month 6 (weeks 21 - 24 post baseline)
Any Cocaine Use
Any cocaine using self report, binary measure of percent days cocaine use.
Measured: Month 3 (weeks 9 - 12 post baseline)
Any Cocaine Use
Any cocaine using self report, binary measure of percent days cocaine use
Measured: Month 4 (weeks 13 - 16 post baseline)
Any Cocaine Use
Any cocaine using self report, binary measure of percent days cocaine use
Measured: Month 5 (weeks 17 - 20 post baseline)
Any Cocaine Use
Any cocaine using self report, binary measure of percent days cocaine use
Measured: Month 6 (weeks 21 - 24 post baseline)
Percent Days Cocaine Use
Percent days of any cocaine use, self reported
Measured: Month 3 (weeks 9 - 12 post baseline)
Percent Days Cocaine Use
Percent days of any cocaine use, self reported
Measured: Month 5 (weeks 17 - 20 post baseline)
Percent Days Cocaine Use
Percent days of any cocaine use, self reported
Measured: Month 6 (weeks 21 - 24 post baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2009 (estimated)
- Study startOct 2008
- Primary completionDec 2013
- Study completionDec 2013
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.
- Other trials for Substance Use DisordersStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James R. McKay, Ph.D, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01032135
- Sponsor's protocol ID
- 807092
- Other IDs
- IND: 101,486
- Status last verified
- Aug 2017
- First submitted
- 14 Dec 2009
- Last updated
- 5 Sep 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptive Treatment for Alcohol and Cocaine Dependence
- ClinicalTrials.gov ID
- NCT01032135
- Acronym / sponsor ID
- 807092
- Conditions
- Substance Use Disorders
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 15 Dec 2009 (estimated)
- Results
- Posted 15 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- Primary objective #1: Determine the relative effectiveness of MI-IOP and MI-PC in the full study sample with regard to treatment engagement over weeks 1-12 and cocaine/alcohol use over weeks 1-24.
- Hypothesis 1: An intervention that explores several possible treatment options with the patient and provides the chosen option (e.g., MI-PC) will produce higher rates of treatment engagement than an intervention focused on engagement in IOP only (e.g., MI-IOP).
- Hypothesis 2: An intervention that explores several possible treatment options with the patient and provides the chosen option (e.g., MI-PC) will produce better cocaine/alcohol use outcomes than an intervention focused on engagement in IOP only (MI-IOP).
- Secondary analysis 1: Among the Non-engaged patients, determine rates of selection of each of the three options in MI-PC, retention rates within each option, and cocaine/alcohol use outcomes in each option.
- Secondary analysis 2: Among the Engaged patients, determine rates of selection of each of the three options in MI-PC, retention rates within each option, and cocaine/alcohol use outcomes in each option.
- Primary objective #2: Determine whether the relative effectiveness of MI-IOP and MI-PC varies as a function of engagement group, with regard to treatment engagement over weeks 1-12 and cocaine/alcohol use outcomes over weeks 1-24.
- Hypothesis 1: The predicted main effect on retention favoring MI-PC over MI-IOP will be significantly larger among patients in the Non-engaged group than among those in the Engaged group.
- Hypothesis 2: The predicted main effect on cocaine/alcohol use outcomes favoring MI-PC over MI-IOP will be significantly larger among patients in the Non-engaged group than among those in the Engaged group.
Detailed description
- Secondary objective #1: Examine outcomes on three secondary measures: percent days abstinent from all substances, negative consequences of drug use, and HIV high risk behaviors.
- Hypothesis 1: Outcomes on the secondary measures will be better in MI-PC than in MI-IOP.
- Secondary objective #2: Test hypotheses concerning potential mediators of the predicted main effect favoring MI-PC over MI-IOP.
- Hypothesis 1: The predicted advantage of MI-PC over MI-IOP will be mediated by greater increases in motivation, self-efficacy, commitment to abstinence, and self-help involvement in MI-PC.
- Secondary objective #3: Test hypotheses concerning effect of additional MI intervention after initial non-engagement persists through 12 weeks.
- Hypothesis 1: A second telephone MI intervention will produce higher rates of subsequent engagement and less cocaine use than no further MI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1-MI-IOP Engaged | Active comparator | Behavioral: Motivational InterviewingRandomized to treatment as usual, and they attend regularly but dropped out of treatment after randomization. |
| 2-MI-IOP Non-Engaged | Experimental | Behavioral: Motivational Interviewing, Behavioral: Telephone counseling, Behavioral: Cognitive Behavioral Therapy (CBT) Counseling, Drug: medication management, Behavioral: Intensive OutPatient TherapyRandomized to treatment as usual, and do not attend. |
| 3-MI-PC Engaged | Active comparator | Behavioral: Motivational Interviewing, Behavioral: Telephone counseling, Behavioral: Cognitive Behavioral Therapy (CBT) CounselingRandomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization. |
| 4-MI-PC Non-engaged | Experimental | Behavioral: Motivational Interviewing, Behavioral: Telephone counseling, Behavioral: Cognitive Behavioral Therapy (CBT) Counseling, Drug: medication management, Behavioral: Intensive OutPatient TherapyRandomized to treatment choice, and do not attend treatment as usual, so the choice option is used. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- meet DSM-IV criteria for lifetime cocaine or alcohol dependence and have used cocaine or alcohol in the prior 6 months;
- be > 18 years of age;
- be judged clinically appropriate for IOP (e.g., no current psychotic disorder or evidence of severe dementia, and no acute medical problem requiring inpatient treatment;
- have no regular IV heroin use during the past year;
- have access to a telephone;
Key exclusion criteria (3 listed)
- have a current psychotic disorder (as assessed with the psychotic screen from the MINI) or evidence of dementia severe enough to prevent participation in outpatient treatment;
- have acute medical problem requiring immediate inpatient treatment; or
- are currently participating 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 |
|---|---|---|
| Motivational InterviewingAlso: MI2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out. | Behavioural | 1-MI-IOP Engaged, 2-MI-IOP Non-Engaged, 3-MI-PC Engaged, 4-MI-PC Non-engaged |
| Telephone counselingAlso: Telephone based stepped care.one telephone counseling session per week for 10 weeks. | Behavioural | 2-MI-IOP Non-Engaged, 3-MI-PC Engaged, 4-MI-PC Non-engaged |
| Cognitive Behavioral Therapy (CBT) CounselingAlso: CBTOne CBT session per week, for 10 weeks. | Behavioural | 2-MI-IOP Non-Engaged, 3-MI-PC Engaged, 4-MI-PC Non-engaged |
| medication managementAlso: MMPrescription for naltrexone | Drug | 2-MI-IOP Non-Engaged, 4-MI-PC Non-engaged |
| Intensive OutPatient TherapyAlso: IOPReturn to IOP, group therapy 3 times weekly for about three hours a day. | Behavioural | 2-MI-IOP Non-Engaged, 4-MI-PC Non-engaged |
Primary outcome
Treatment Engagement
Time frame: weeks 3 - 12
Number of treatment sessions attended
Treatment Engagement for Participants Engaged at 2 Weeks, But Disengage Before 8 Weeks
Time frame: weeks 9 - 12
Number of treatment sessions attended
Treatment Engagement of Those Non-engaged at 2 Weeks and at 8 Weeks
Time frame: weeks 9 - 12
Number of treatment sessions attended
Any Drinking Days in Previous Month
Time frame: Month 2 (weeks 5 - 8 post baseline)
Days of any drinking in previous month, as reported on Time Line Follow Back. This is a dichotomous measure, so the means that are reported are the percentage of people who have had any days of drinking during the follow up period specified. In other words, 0.57 indicates that 57% of the sample drank in the follow up period.
Any Drinking Days in Previous Month
Time frame: Month 3 (weeks 9 - 12 post baseline)
Any drinking days during previous month, as reported on Time Line Follow Back. This is a dichotomous measure, so the means that are reported are the percentage of people who have had any days of drinking during the follow up period specified. In other words, 0.57 indicates that 57% of the sample drank in the follow up period.
Any Drinking
Time frame: Month 4 (weeks 13 - 15 post baseline)
Any drinking at follow up, as reported on Time Line Follow Back. This is a dichotomous measure, so the means that are reported are the percentage of people who have had any days of drinking during the follow up period specified. In other words, 0.57 indicates that 57% of the sample drank in the follow up period.
Any Drinking
Time frame: Month 5 (weeks 16 - 20 post baseline)
Any drinking at follow up, as reported on Time Line Follow Back, This is a dichotomous measure, so the means that are reported are the percentage of people who have had any days of drinking during the follow up period specified. In other words, 0.57 indicates that 57% of the sample drank in the follow up period.
Any Drinking
Time frame: Month 6 (weeks 21 - 24 post baseline)
Any drinking at follow up, as reported on Time Line Follow Back. This is a dichotomous measure, so the means that are reported are the percentage of people who have had any days of drinking during the follow up period specified. In other words, 0.57 indicates that 57% of the sample drank in the follow up period.
Percent Days Drinking
Time frame: Month 2 (weeks 5 - 8 post baseline)
Percent days of any drinking at follow up, from Time Line Follow Back
Percent Days Drinking
Time frame: Month 3 (weeks 9 - 12 post baseline)
Percent days of any drinking at follow up, from Time Line Follow Back
Percent Days Drinking
Time frame: Month 4 (weeks 13 - 16 post baseline)
Percent days of any drinking at follow up, from Time Line Follow Back
Percent Days Drinking
Time frame: Month 5 (weeks 17 - 20 post baseline)
Percent days of any drinking at follow up, fromTime Line Follow Back
Percent Days Drinking
Time frame: Month 6 (weeks 21 - 24)
Percent days of any drinking at follow up, from Time Line Follow Back
Any Heavy Drinking Days
Time frame: Month 2 (weeks 5 - 8 post baseline)
days of five or more drinks per drinking day for men, four or more drinks per drinking day for women, at follow up, from Time Line Follow Back. This is a dichotomous measure, so the means that are reported are the percentage of people who have had any days of heavy drinking during the follow up period specified. In other words, 0.57 indicates that 57% of the sample engaged in heavy drinking in the follow up period.
Any Heavy Drinking Days
Time frame: Month 3 (weeks 9 - 12 post baseline)
five or more drinks per drinking day for men, four or more drinks per drinking day for women, at follow up, from Time Line Follow Back. This is a dichotomous measure, so the means that are reported are the percentage of people who have had any days of heavy drinking during the follow up period specified. In other words, 0.57 indicates that 57% of the sample engaged in heavy drinking in the follow up period.
Any Heavy Drinking Days
Time frame: Month 4 (weeks 13 - 16 post baseline)
five or more drinks per drinking day for men, four or more drinks per drinking day for women at follow up, from Time Line Follow Back. This is a dichotomous measure, so the means that are reported are the percentage of people who have had any days of heavy drinking during the follow up period specified. In other words, 0.57 indicates that 57% of the sample engaged in heavy drinking in the follow up period.
Any Heavy Drinking Days
Time frame: Month 5 (weeks 17 to 20 post baseline)
five or more drinks per day for men, four or more drinks per day for women, from Time Line Follow Back. This is a dichotomous measure, so the means that are reported are the percentage of people who have had any days of heavy drinking during the follow up period specified. In other words, 0.57 indicates that 57% of the sample engaged in heavy drinking in the follow up period.
Any Heavy Drinking Days
Time frame: Month 6 (weeks 21 - 24 post baseline)
five or more drinks per day for men, four or more drinks per day for women, from Time Line Follow Back. This is a dichotomous measure, so the means that are reported are the percentage of people who have had any days of heavy drinking during the follow up period specified. In other words, 0.57 indicates that 57% of the sample engaged in heavy drinking in the follow up period.
Percent Days Heavy Drinking
Time frame: Month 2 (weeks 5 - 8 post baseline)
Percent days heavy drinking at follow up, from Time Line Follow Back *heavy drinking is defined as five or more drinks per day for men, four or more for women
Percent Days Heavy Drinking
Time frame: Month 3 (weeks 9 - 12 post baseline)
Percent days heavy drinking at follow up, from Time Line Follow Back * heavy drinking is defined as five or more drinks per day for men, four or more for women.
Percent Days Heavy Drinking
Time frame: Month 4 (weeks 13 - 16 post baseline)
Percent days heavy drinking at follow up, from Time Line Follow Back *heavy drinking is defined as five or more drinks per drinking day for men, four or more for women
Percent Days Heavy Drinking
Time frame: Month 5 ( weeks 17 - 20 post baseline)
Percent days heavy drinking at follow up, from Time Line Follow Back * heavy drinking is defined as five or more drinks per drinking day for men, four or more for women
Percent Days Heavy Drinking
Time frame: Month 6 (weeks 21 - 24 post baseline)
Percent days heavy drinking at follow up, from Time Line Follow Back *heavy drinking is defined as five or more drinks per drinking day for men, four or more for women
Any Cocaine Use
Time frame: Month 3 (weeks 9 - 12 post baseline)
Any cocaine using self report, binary measure of percent days cocaine use.
Any Cocaine Use
Time frame: Month 4 (weeks 13 - 16 post baseline)
Any cocaine using self report, binary measure of percent days cocaine use
Any Cocaine Use
Time frame: Month 5 (weeks 17 - 20 post baseline)
Any cocaine using self report, binary measure of percent days cocaine use
Any Cocaine Use
Time frame: Month 6 (weeks 21 - 24 post baseline)
Any cocaine using self report, binary measure of percent days cocaine use
Percent Days Cocaine Use
Time frame: Month 3 (weeks 9 - 12 post baseline)
Percent days of any cocaine use, self reported
Percent Days Cocaine Use
Time frame: Month 5 (weeks 17 - 20 post baseline)
Percent days of any cocaine use, self reported
Percent Days Cocaine Use
Time frame: Month 6 (weeks 21 - 24 post baseline)
Percent days of any cocaine use, self reported
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
James R. McKay, Ph.D principal investigator
University of Pennsylvania
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Motivational Interviewing, Telephone counseling and Cognitive Behavioral Therapy (CBT) Counseling in people with Substance Use Disorders, run by University of Pennsylvania at 3 sites 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 9 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 5 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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.
What does this combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 May 2017). 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?
Treatment Engagement (time frame: weeks 3 - 12). The study lists 30 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 5 Sep 2017.