Intensive Outpatient Versus Outpatient Treatment With Buprenorphine Among African Americans

• Sponsor: Friends Research Institute, Inc. (Other)
• Overall Status: Completed
• CT.gov ID: NCT01096550
• Collaborator: National Institute on Drug Abuse (NIDA) (NIH)
• Enrollment: 319
• Location: 1
• Arms: 2
• Duration (Months): 19
• Patients Per Site Per Month: 16.8

Study Details

Study Description

Brief Summary

The purpose of this study is to compare the effectiveness of different levels of counseling (intensive outpatient versus standard outpatient) on treatment outcomes for African American adult patients receiving buprenorphine in 2 formerly "drug-free" programs.

Condition or Disease	Intervention/Treatment	Phase
Drug Dependence	Behavioral: Outpatient; Behavioral: Intensive Outpatient	N/A

Detailed Description

This two-group randomized clinical trial will test the effectiveness of intensive outpatient (IOP) v. standard outpatient (OP) treatment in 272 heroin-dependent African American adults receiving buprenorphine in 2 formerly "drug-free" programs. Participants will be randomly assigned to one of the two treatment intensity conditions at intake and assessed at baseline, 3-, and 6-months post-baseline to determine treatment retention, frequency and severity of heroin and cocaine use, self-reported HIV-risk, quality of life, and to determine DSM-IV criteria for Full or Partial Remission of Opioid Dependence. Furthermore, patient factors potentially critical for treatment success (e.g., attitudes towards buprenorphine and average buprenorphine dose while in treatment) will be examined to determine their importance in influencing treatment outcomes. Moreover, both patient and staff attitudes and average buprenorphine dose will be evaluated to determine their respective relationships to treatment experiences and treatment retention.

Study Design

• Study Type: Interventional
• Actual Enrollment: 319 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Intensive Outpatient v. Outpatient Treatment With Buprenorphine Among African Americans
• Study Start Date: Mar 1, 2010
• Actual Primary Completion Date: Oct 1, 2011
• Actual Study Completion Date: Oct 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intensive Outpatient Buprenorphine patients receiving 9 or more hours of outpatient counseling.	Behavioral: Intensive Outpatient; Buprenorphine patients receiving 9 or more hours of outpatient counseling.
Active Comparator: Outpatient Buprenorphine patients receiving between 2 and 8 hours of outpatient counseling.	Behavioral: Outpatient; Buprenorphine patients receiving 2 to 8 hours of outpatient counseling.

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants Meeting Diagnosis of Opioid Dependence on Composite International Diagnostic Interview-2 (CIDI-2) [6 months post-baseline]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• heroin-dependent adults

• new admissions to buprenorphine outpatient treatment

Exclusion Criteria:

• pregnancy

• acute medical or psychiatric illness

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Friends Research Institute	Baltimore	Maryland	United States	21201

Sponsors and Collaborators

• Friends Research Institute, Inc.
• National Institute on Drug Abuse (NIDA)

Investigators

• Principal Investigator: Shannon G Mitchell, PhD, Friends Research Institute, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Friends Research Institute, Inc.
• ClinicalTrials.gov Identifier: NCT01096550
• Other Study ID Numbers: 1RC1DA028407-01; 1RC1DA028407-01
• First Posted: Mar 31, 2010
• Last Update Posted: Apr 8, 2020
• Last Verified: Mar 1, 2020

• Keywords provided by Friends Research Institute, Inc.: opioid dependence; outpatient treatment; intensive outpatient treatment
• Additional relevant MeSH terms: Substance-Related Disorders

Study Results

Participant Flow

Recruitment Details	New patients entering buprenorphine treatment at one of the two participating outpatient "drug-free" treatment programs were block randomized to either intensive outpatient treatment (IOP) or standard outpatient treatment (OP). The study initially included a third clinic site, which was dropped due to insufficient enrollment at that site.
Pre-assignment Detail	345 patients were randomized. Of those, the following participants were excluded from the study shortly after random assignment: 21 were from the discontinued site, 2 were dropped because of non-standard clinic treatment track, 1 voluntarily withdrew, 2 were erroneously re-enrolled. We also excluded 19 non-African Americans, per study protocol.

Arm/Group Title	Intensive Outpatient	Outpatient
Arm/Group Description	Buprenorphine patients receiving 9 or more hours of outpatient counseling. Intensive Outpatient : Buprenorphine patients receiving 9 or more hours of outpatient counseling.	Buprenorphine patients receiving between 2 and 8 hours of outpatient counseling. Outpatient : Buprenorphine patients receiving 2 to 8 hours of outpatient counseling.
Period Title: Overall Study
STARTED	170	175
COMPLETED	133	146
NOT COMPLETED	37	29

Baseline Characteristics

Arm/Group Title	Intensive Outpatient	Outpatient	Total
Arm/Group Description	Buprenorphine patients receiving 9 or more hours of outpatient counseling. Intensive Outpatient : Buprenorphine patients receiving 9 or more hours of outpatient counseling.	Buprenorphine patients receiving between 2 and 8 hours of outpatient counseling. Outpatient : Buprenorphine patients receiving 2 to 8 hours of outpatient counseling.	Total of all reporting groups
Overall Participants	170	175	345
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	168 98.8%	174 99.4%	342 99.1%
>=65 years	2 1.2%	1 0.6%	3 0.9%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	44.15 (8.15)	46.27 (6.75)	45.23 (7.53)
Sex: Female, Male (Count of Participants)
Female	62 36.5%	67 38.3%	129 37.4%
Male	108 63.5%	108 61.7%	216 62.6%
Region of Enrollment (participants) [Number]
United States	170 100%	175 100%	345 100%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants Meeting Diagnosis of Opioid Dependence on Composite International Diagnostic Interview-2 (CIDI-2)
Time Frame	6 months post-baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intensive Outpatient	Outpatient
Arm/Group Description	Buprenorphine patients receiving 9 or more hours of outpatient counseling. Intensive Outpatient : Buprenorphine patients receiving 9 or more hours of outpatient counseling.	Buprenorphine patients receiving between 2 and 8 hours of outpatient counseling. Outpatient : Buprenorphine patients receiving 2 to 8 hours of outpatient counseling.
Measure Participants	145	155
Number [percentage of opioid dependent subjects]	20	21

Adverse Events

Adverse Event Reporting Description	serious and/or other [non-serious] adverse events were not collected/assessed
Arm/Group Title	Intensive Outpatient		Outpatient
Arm/Group Description	Buprenorphine patients receiving 9 or more hours of outpatient counseling. Intensive Outpatient : Buprenorphine patients receiving 9 or more hours of outpatient counseling.		Buprenorphine patients receiving between 2 and 8 hours of outpatient counseling. Outpatient : Buprenorphine patients receiving 2 to 8 hours of outpatient counseling.
All Cause Mortality
	Intensive Outpatient		Outpatient
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Intensive Outpatient		Outpatient
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Intensive Outpatient		Outpatient
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

OP condition participants received more counseling services at the clinics as part of their regular care than was initially expected and IOP condition participants received slightly less that 9 hours of counseling, on average.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.