Buprenorphine Maintenance Treatment of Opioid Dependence in Primary Care: A Randomized Clinical Trial

• Sponsor: New York State Psychiatric Institute (Other)
• Overall Status: Completed
• CT.gov ID: NCT00684554
• Collaborator: National Institute on Drug Abuse (NIDA) (NIH)
• Enrollment: 20
• Location: 1
• Arms: 2
• Duration (Months): 28
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief Summary

The study will assess the effectiveness of at-home vs. in-office induction for patients entering buprenorphine maintenance at Associates in Internal Medicine (AIM) primary care clinic.

Condition or Disease	Intervention/Treatment	Phase
Opioid-Related Disorders; Heroin Dependence	Drug: Buprenorphine	Phase 2/Phase 3

Detailed Description

Buprenorphine maintenance is an effective treatment for opioid dependence, yet diffusion has been limited. Physician concern about induction is a reported barrier, primarily as buprenorphine may precipitate withdrawal due to its partial opioid agonist activity and high receptor binding affinity. To minimize risk, guidelines recommend in-office assessment and monitoring during induction. As this may not be feasible (e.g., time limitations), many patients are instructed to self-induct at home. While this may facilitate treatment entry, data on at-home induction are limited. The study will assess the effectiveness of at-home vs. in-office induction for patients entering buprenorphine maintenance at Associates in Internal Medicine (AIM) primary care clinic. Currently, patients receive buprenorphine maintenance at AIM as part of standard clinical practice and through an observational study (IRB 5258). Most patients are insured through Medicaid, which covers visit, medication (obtained through prescription from a local pharmacy), lab, and outside psychosocial treatment cost. In this demonstration project, 20 opioid dependent patients will be randomly assigned to at-home or in-office induction, and then monitored for 12 weeks. Ancillary psychosocial treatment will be encouraged but not required. After randomization, AIM clinic and NYSPI research visits will be scheduled weekly for 4 weeks, and then at weeks 8 and 12. The primary outcome will include a comparison of the proportion of patients successfully inducted one week after the initial primary care visit. Secondary outcomes will include: 1) Time to stabilization after buprenorphine initiation assessed by: a) Time until the patient is without withdrawal for two consecutive days, and b) Time until the patient is opioid free for two consecutive weeks; and 3) Retention-in-treatment at 4 and 12 weeks. Other secondary outcomes include patient satisfaction and change in addiction severity. These data will provide important information in buprenorphine initiation in primary care and enable determination of treatment effects size prior to future clinical trials.

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Buprenorphine Maintenance Treatment of Opioid Dependence in Primary Care: A Randomized Clinical Trial of At-Home Versus In-Office Buprenorphine Induction
• Study Start Date: Dec 1, 2007
• Actual Primary Completion Date: Aug 1, 2008
• Actual Study Completion Date: Apr 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Unobserved-at home Buprenorphine Unobserved at home induction	Drug: Buprenorphine; Dose is determined according to the participants' individual need.; Other Names: Bup
Active Comparator: Observed Buprenorphine Observed in office induction	Drug: Buprenorphine; Dose is determined according to the participants' individual need.; Other Names: Bup

Outcome Measures

Primary Outcome Measures

1. The Primary Outcome Will Include a Comparison of the Proportion of Patients Successfully Inducted One Week After the Initial Primary Care Visit. [one week after initial primary care visit]

   The primary outcome will include a comparison of the proportion of patients successfully inducted one week after the initial primary care visit. Defined as in treatment, on Buprenorphine and withdrawal free.

Secondary Outcome Measures

1. Prolonged Withdrawal [a) 2 days]

   participants experiencing prolonged withdrawal beyond two days after buprenorphine induction

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. DSM-IV criteria for current opioid dependence with physical dependence and are seeking treatment

2. Recent opioid use

3. Individuals must describe opioids as their primary drug of abuse.

4. 18-65 years of age

5. Able to give informed consent and comply with study procedures

6. Financially able to receive treatment at AIM and obtain medication (e.g., Medicaid)

Exclusion Criteria:

1. DSM-IV opioid dependence without physical dependence

2. Any current Axis I psychiatric disorder(s) as defined by DSM-IV-TR that in the investigator's judgment are unstable or would be disrupted by study participation (e.g., psychosis, active suicidal or homicidal ideation).

3. Individuals who are significant risk for suicide based on their current mental state or history.

4. DSM-IV alcohol or benzodiazepine dependence with physiologic dependence.

5. Pregnancy, lactation. Women must also agree to use a method of contraception with proven efficacy and agree not to become pregnant during the study.

6. Unstable physical disorder that might make participation hazardous.

7. Individuals with a known allergy, sensitivity or adverse reaction to buprenorphine.

8. Past life-threatening idiosyncratic severe opioid withdrawal reaction (e.g., psychosis, seizure)

9. Current buprenorphine maintenance

10. Current long-acting opioid use (e.g., methadone)

11. Inability to read or understand the self-report assessment forms unaided

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Columbia University/New York State Psychiatric Institute	New York	New York	United States	10032

Sponsors and Collaborators

• New York State Psychiatric Institute
• National Institute on Drug Abuse (NIDA)

Investigators

• Principal Investigator: Erik W Gunderson, M.D., Columbia University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Frances R Levin, Director of Substance Use Disorder, New York State Psychiatric Institute
• ClinicalTrials.gov Identifier: NCT00684554
• Other Study ID Numbers: #5600; K23DA020000
• First Posted: May 26, 2008
• Last Update Posted: Apr 24, 2019
• Last Verified: Apr 1, 2019

• Keywords provided by Frances R Levin, Director of Substance Use Disorder, New York State Psychiatric Institute: Heroin Dependence; Opioid Dependence; Primary Care; Buprenorphine
• Additional relevant MeSH terms: Opioid-Related Disorders; Heroin Dependence; Buprenorphine

Study Results

Participant Flow

Recruitment Details	Twenty patients were recruited between December 2007-June 2008 through referrals from clinical and research groups at Columbia University Medical Center and locally posted flyers.
Pre-assignment Detail	After a structured telephone interview, participants completed in-person screening after obtaining informed consent. Of the 21 patients screened, one was excluded for active alcohol and benzodiazepine dependence.

Arm/Group Title	Unobserved-at Home	Observed
Arm/Group Description	Buprenorphine Unobserved at home induction Buprenorphine: Dose is determined according to the participants' individual need.	Buprenorphine Observed in office induction Buprenorphine: Dose is determined according to the participants' individual need.
Period Title: Overall Study
STARTED	10	10
COMPLETED	10	10
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Unobserved-at Home	Observed	Total
Arm/Group Description	Buprenorphine Unobserved at home induction Buprenorphine: Dose is determined according to the participants' individual need.	Buprenorphine Observed in office induction Buprenorphine: Dose is determined according to the participants' individual need.	Total of all reporting groups
Overall Participants	10	10	20
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	10 100%	10 100%	20 100%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	1 10%	1 10%	2 10%
Male	9 90%	9 90%	18 90%
Region of Enrollment (participants) [Number]
United States	10 100%	10 100%	20 100%

Outcome Measures

1. Primary Outcome

Title	The Primary Outcome Will Include a Comparison of the Proportion of Patients Successfully Inducted One Week After the Initial Primary Care Visit.
Description	The primary outcome will include a comparison of the proportion of patients successfully inducted one week after the initial primary care visit. Defined as in treatment, on Buprenorphine and withdrawal free.
Time Frame	one week after initial primary care visit

Outcome Measure Data

Analysis Population Description

patients who in initiated induction

Arm/Group Title	Unobserved-at Home	Observed
Arm/Group Description	Buprenorphine Unobserved at home induction Buprenorphine: Dose is determined according to the participants' individual need.	Buprenorphine Observed in office induction Buprenorphine: Dose is determined according to the participants' individual need.
Measure Participants	10	10
Number [participants]	6 60%	6 60%

2. Secondary Outcome

Title	Prolonged Withdrawal
Description	participants experiencing prolonged withdrawal beyond two days after buprenorphine induction
Time Frame	a) 2 days

Outcome Measure Data

Analysis Population Description

participants who initiated induction

Arm/Group Title	Unobserved-at Home	Observed
Arm/Group Description	Buprenorphine Unobserved at home induction Buprenorphine: Dose is determined according to the participants' individual need.	Buprenorphine Observed in office induction Buprenorphine: Dose is determined according to the participants' individual need.
Measure Participants	10	10
Number [participants]	3 30%	3 30%

Adverse Events

Time Frame	12 weeks
Arm/Group Title	Unobserved-at Home		Observed
Arm/Group Description	Buprenorphine Unobserved at home induction Buprenorphine: Dose is determined according to the participants' individual need.		Buprenorphine Observed in office induction Buprenorphine: Dose is determined according to the participants' individual need.
All Cause Mortality
	Unobserved-at Home		Observed
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Unobserved-at Home		Observed
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/10 (0%)
Other (Not Including Serious) Adverse Events
	Unobserved-at Home		Observed
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/10 (30%)		3/10 (30%)
Gastrointestinal disorders
Prolonged withdrawal	3/10 (30%)	3	3/10 (30%)	3

Limitations/Caveats

The primary pilot study limitations are sample size and treatment setting, which restricts statistical comparison of outcomes and generalizability.

More Information

Certain Agreements

All Principal Investigators ARE 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.