Phase 3 N=500 Randomized Treatment

Adaptive Treatment for Alcohol and Cocaine Dependence

Substance Use Disorders

Bottom Line

View on ClinicalTrials.gov: NCT01032135 ↗

Enrolled (actual)

500

Serious AEs

13.4%

Results posted

May 2017

Primary outcome: Primary: Treatment Engagement — 3.92; 3.50 treatment days — p=0.11

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Motivational Interviewing (Behavioral); Telephone counseling (Behavioral); Cognitive Behavioral Therapy (CBT) Counseling (Behavioral); medication management (Drug); Intensive OutPatient Therapy (Behavioral)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: University of Pennsylvania
Primary completion: Dec 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Treatment Engagement	3.92; 3.50	0.11
PRIMARY Treatment Engagement for Participants Engaged at 2 Weeks, But Disengage Before 8 Weeks	1.28; 0.76	0.02 sig
PRIMARY Treatment Engagement of Those Non-engaged at 2 Weeks and at 8 Weeks	0.58; 0.30	0.005 sig
PRIMARY Any Drinking Days in Previous Month	0.58; 0.37; 0.57; 0.42; 0.72; 0.50	—
PRIMARY Any Drinking Days in Previous Month	0.58; 0.37; 0.57; 0.42; 0.72; 0.50	—
PRIMARY Any Drinking	0.56; 0.31; 0.50; 0.27; 0.42; 0.63	0.0007 sig
PRIMARY Any Drinking	0.56; 0.31; 0.50; 0.27; 0.42; 0.63	0.0007 sig
PRIMARY Any Drinking	0.56; 0.31; 0.50; 0.27; 0.42; 0.63	0.0007 sig
PRIMARY Percent Days Drinking	14.75; 5.66; 19.05; 8.77; 8.70; 15.38	0.009 sig
PRIMARY Percent Days Drinking	14.75; 5.66; 19.05; 8.77; 8.70; 15.38	0.009 sig
PRIMARY Percent Days Drinking	14.75; 5.66; 19.05; 8.77; 8.70; 15.38	0.009 sig
PRIMARY Percent Days Drinking	14.75; 5.66; 19.05; 8.77; 8.70; 15.38	0.009 sig
PRIMARY Percent Days Drinking	14.75; 5.66; 19.05; 8.77; 8.70; 15.38	0.009 sig
PRIMARY Any Heavy Drinking Days	0.43; 0.17; 0.38; 0.21; 0.25; 0.37	0.0001 sig
PRIMARY Any Heavy Drinking Days	0.43; 0.17; 0.38; 0.21; 0.25; 0.37	0.0001 sig
PRIMARY Any Heavy Drinking Days	0.43; 0.17; 0.38; 0.21; 0.25; 0.37	0.0001 sig
PRIMARY Any Heavy Drinking Days	0.43; 0.17; 0.38; 0.21; 0.25; 0.37	0.0001 sig
PRIMARY Any Heavy Drinking Days	0.43; 0.17; 0.38; 0.21; 0.25; 0.37	0.0001 sig
PRIMARY Percent Days Heavy Drinking	11.30; 3.77; 18.3; 5.74; 7.61; 10.87	0.003 sig
PRIMARY Percent Days Heavy Drinking	11.30; 3.77; 18.3; 5.74; 7.61; 10.87	0.003 sig
PRIMARY Percent Days Heavy Drinking	11.30; 3.77; 18.3; 5.74; 7.61; 10.87	0.003 sig
PRIMARY Percent Days Heavy Drinking	11.30; 3.77; 18.3; 5.74; 7.61; 10.87	0.003 sig
PRIMARY Percent Days Heavy Drinking	11.30; 3.77; 18.3; 5.74; 7.61; 10.87	0.003 sig
PRIMARY Any Cocaine Use	0.35; 0.49; 0.35; 0.30; 0.54; 0.58	0.13
PRIMARY Any Cocaine Use	0.35; 0.49; 0.35; 0.30; 0.54; 0.58	0.13
PRIMARY Any Cocaine Use	0.35; 0.49; 0.35; 0.30; 0.54; 0.58	0.13
PRIMARY Any Cocaine Use	0.35; 0.49; 0.35; 0.30; 0.54; 0.58	0.13
PRIMARY Percent Days Cocaine Use	7.76; 9.50; 10.09; 4.95; 15.57; 13.35	0.75
PRIMARY Percent Days Cocaine Use	7.76; 9.50; 10.09; 4.95; 15.57; 13.35	0.75
PRIMARY Percent Days Cocaine Use	7.76; 9.50; 10.09; 4.95; 15.57; 13.35	0.75

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. * 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. 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/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.

Eligibility Criteria

Inclusion Criteria

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
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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01032135). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.