Adaptive Treatment for Cocaine Dependence
| Status: | Completed |
|---|---|
| Conditions: | Psychiatric, Pulmonary |
| Therapuetic Areas: | Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 4/21/2016 |
| Start Date: | October 2008 |
| End Date: | December 2013 |
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 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 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 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 use outcomes in each option.
2. 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 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 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.
full study sample with regard to treatment engagement over weeks 1-12 and cocaine 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 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 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 use outcomes in each option.
2. 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 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 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.
3. 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.
4. 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.
5. 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.
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.
4. 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.
5. 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.
Inclusion Criteria:
1. meet DSM-IV criteria for lifetime cocaine dependence and have used cocaine in the
prior 6 months;
2. be > 18 years of age;
3. 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;
4. have no regular IV heroin use during the past year;
5. have access to a telephone;
6. be willing to be randomized and participate in research; and
7. no current participation in methadone or other forms of DA treatment, other than IOP.
Finally, because of study follow-up requirements, subjects will
8. be required to be metropolitan area residents, and
9. 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.
Exclusion Criteria:
1. 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;
2. have acute medical problem requiring immediate inpatient treatment; or
3. are currently participating in methadone or other forms of DA treatment, other than
IOP.
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