Adaptive Treatment for Cocaine Dependence - Full Text View

Purpose

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.
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.

Condition	Intervention	Phase
Cocaine Dependence	Behavioral: Motivational Interviewing Behavioral: Telephone counseling Behavioral: Cognitive Behavioral Therapy (CBT) Counseling	Phase 2 Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Adaptive Treatment for Cocaine Dependence

Resource links provided by NLM:

Drug Information available for: Cocaine hydrochloride

U.S. FDA Resources

Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:

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. [ Time Frame: engagment measured to week 12, cocaine use measured to week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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. [ Time Frame: Engagement measured until week 12, cocaine use measured until week 24. ] [ Designated as safety issue: No ]

Estimated Enrollment:	300
Study Start Date:	October 2008
Estimated Study Completion Date:	December 2013
Estimated Primary Completion Date:	December 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1-MI-IOP Engaged Randomized to treatment as usual, and they attend regularly.	Behavioral: Motivational Interviewing 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out. Other Name: MI
Experimental: 2-MI-IOP Non-Engaged Randomized to treatment as usual, and do not attend.	Behavioral: Motivational Interviewing 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out. Other Name: MI Behavioral: Telephone counseling one telephone counseling session per week for 10 weeks. Other Name: Telephone based stepped care. Behavioral: Cognitive Behavioral Therapy (CBT) Counseling One CBT session per week, for 10 weeks. Other Name: CBT
3-MI-PC Engaged Randomized to treatment choice, but remain attending treatment as usual.	Behavioral: Motivational Interviewing 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out. Other Name: MI Behavioral: Telephone counseling one telephone counseling session per week for 10 weeks. Other Name: Telephone based stepped care. Behavioral: Cognitive Behavioral Therapy (CBT) Counseling One CBT session per week, for 10 weeks. Other Name: CBT
Experimental: 4-MI-PC Randomized to treatment choice, and do not attend treatment as usual, so the choice option is used.	Behavioral: Motivational Interviewing 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out. Other Name: MI Behavioral: Telephone counseling one telephone counseling session per week for 10 weeks. Other Name: Telephone based stepped care. Behavioral: Cognitive Behavioral Therapy (CBT) Counseling One CBT session per week, for 10 weeks. Other Name: CBT

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

meet DSM-IV criteria for lifetime cocaine dependence and have used cocaine 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
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.

Exclusion Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01032135

Locations

United States, Pennsylvania
Presbyterian Medical Center
Philadelphia, Pennsylvania, United States, 19104
NorthEast Treatment Center
Philadelphia, Pennsylvania, United States, 19123
VAMC
Philadelphia, Pennsylvania, United States, 19104

Sponsors and Collaborators

University of Pennsylvania

More Information

No publications provided

Responsible Party:	James R. McKay, Ph.D., University of Pennsylvania
ClinicalTrials.gov Identifier:	NCT01032135 History of Changes
Other Study ID Numbers:	807092, IND: 101,486
Study First Received:	December 14, 2009
Last Updated:	August 3, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Cocaine-Related Disorders
Substance-Related Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 19, 2013