Buprenorphine as a Treatment in Opiate Dependent Pain Patients

• Sponsor: State University of New York at Buffalo (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00552578
• Collaborator: (none)
• Enrollment: 12
• Location: 1
• Arms: 2
• Duration (Months): 12
• Patients Per Site Per Month: 1

Study Details

Study Description

Brief Summary

This study is designed to determine if different doses of buprenorphine (either tapering doses or steady doses) are effective in managing chronic, non-cancer pain in individuals who also are addicted to opiate pain medicines.

Condition or Disease	Intervention/Treatment	Phase
Opiate Addiction; Refractory Pain	Drug: buprenorphine/naloxone; Drug: buprenorphine/naloxone	Phase 4

Detailed Description

Context: Some individuals have two conditions: 1) a well-documented pain disorder and 2) clear evidence of a substance use disorder with opiate dependency. It is not known how to manage these patients. In addition to other modalities for the treatment of chronic pain, combination tablets of buprenorphine/naloxone (Suboxone) may be helpful.

Objective: The objective of this study is to determine if the addition of pharmacotherapy with Suboxone to usual care would improve clinical outcome relative to usual care alone.

Design: Randomized control trial.

Setting: The study will be conducted in the out-patient clinics of a tertiary-care teaching hospital.

Participants: The participants will be those who have: 1) a well-documented pain disorder and 2) clear evidence of a substance use disorder with opiate dependency.

Baseline data collected: Data collected at baseline will include (with examples):

demographics (age, gender, race), substance use history (type of substances used, duration of use, routes of abuse), type of pain disorder (previous traumatic injury, musculoskeletal, neuropathic), co-existing medical problems (seizures, hepatitis C), prior injuries (accidents, interpersonal violence), prior mental health problems (prior treatment, diagnoses), prior substance abuse treatment (outpatient, inpatient), socioeconomic variables (educational level, occupation, employment history), criminal history (number of arrests and convictions, total amount of time spent in jail or prison), family history (first degree relatives with substance use disorders) and scores on psychometric testing (ASI).

Outcome data: Three main outcome variables will be examined relapse to substance use (as documented by toxicology), quality of life, and successful participation in the pain management program for six months, which included the completion of the study buprenorphine treatment protocols.

Data analyses: Outcome variables will be compared between the two groups using t-tests or chi-square tests as appropriate. A Kaplan-Myer survival analysis will be used to describe participant participation. Predictors of poor outcomes will be identified using a case-control design in which those with poor outcomes (the "cases") will be compared to those with successful outcomes (the "controls") using multivariate techniques (logistic regression).

Study Design

• Study Type: Interventional
• Actual Enrollment: 12 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Randomized Controlled Trial Testing Buprenorphine as a Treatment in Opiate Dependent Pain Patients
• Study Start Date: Oct 1, 2007
• Actual Primary Completion Date: Oct 1, 2008
• Actual Study Completion Date: Oct 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Tapering doses of buprenorphine Participants assigned to this arm will receive tapering doses of buprenorphine for detoxification.	Drug: buprenorphine/naloxone; sublingual tablets, 2/0.5 mg, three times a day for one month, twice a day for one month, once a day for one month, then every other day for one month. (dose may be adjusted based on an individual's response); Other Names: Suboxone
Experimental: Steady doses of buprenrophine Participants assigned to this arm will receive a steady dose of buprenorphine for maintenance.	Drug: buprenorphine/naloxone; sublingual tablets, 2/0.5 mg, one tablet three times a day for six months (doses may be adjusted based on an individual's response; Other Names: Suboxone

Outcome Measures

Primary Outcome Measures

1. Relapse to Substance Abuse [Six months]

   Relapse to substance abuse (yes/no) was determined by participant self-report or by a positive urine toxicology.

Secondary Outcome Measures

1. Number of Participants With Better Overall Quality of Life at Six Months as Compared to Baseline. [Baseline and six months]

   Qualitative measure (better/no change/worse) of participant's perception of overall quality of life related to assigned study protocol arm.

2. Treatment Retention. [Six months]

   "Treatment retention" was defined as the completion of the buprenorphine dosing protocol (i.e., tapering doses vs. steady doses).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Clinical diagnosis of chronic refractory pain

• Clinical diagnosis of opiate dependency

Exclusion Criteria:

• unable to pay for medication

• enrolled in a methadone maintenance program

• homelessness

• major mental illness

• pregnant women

• prisoners

• terminal cancer pain

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Erie County Medical Center	Buffalo	New York	United States	14215

Sponsors and Collaborators

• State University of New York at Buffalo

Investigators

• Principal Investigator: Richard D Blondell, MD, University at Buffalo

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00552578
• Other Study ID Numbers: FMD0400907A
• First Posted: Nov 2, 2007
• Last Update Posted: Feb 17, 2011
• Last Verified: Feb 1, 2011

• Keywords provided by , ,: drug dependence; substance abuse; substance use disorders; myofascial pain syndrome; neuralgia; back pain
• Additional relevant MeSH terms: Pain, Intractable; Opioid-Related Disorders; Buprenorphine; Buprenorphine, Naloxone Drug Combination; Naloxone

Study Results

Participant Flow

Recruitment Details	12 participants recruited Dec 2007 to Apr 2008

Arm/Group Title	Tapering Doses of Buprenorphine	Steady Dose of Buprenorphine
Arm/Group Description	Participants assigned to this arm will receive tapering doses of buprenorphine for detoxification.	Participants assigned to this arm will receive a steady dose of buprenorphine for maintenance.
Period Title: Overall Study
STARTED	6	6
COMPLETED	5	5
NOT COMPLETED	1	1

Baseline Characteristics

Arm/Group Title	Tapering Doses of Buprenorphine	Steady Dose of Buprenorphine	Total
Arm/Group Description	Participants assigned to this arm will receive tapering doses of buprenorphine for detoxification.	Participants assigned to this arm will receive a steady dose of buprenorphine for maintenance.	Total of all reporting groups
Overall Participants	6	6	12
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	6 100%	6 100%	12 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	44 (6)	46 (15)	45 (11)
Sex: Female, Male (Count of Participants)
Female	4 66.7%	2 33.3%	6 50%
Male	2 33.3%	4 66.7%	6 50%
Region of Enrollment (participants) [Number]
United States	6 100%	6 100%	12 100%

Outcome Measures

1. Primary Outcome

Title	Relapse to Substance Abuse
Description	Relapse to substance abuse (yes/no) was determined by participant self-report or by a positive urine toxicology.
Time Frame	Six months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Tapering Doses of Buprenorphine	Steady Dose of Buprenorphine
Arm/Group Description	Participants assigned to this arm will receive tapering doses of buprenorphine for detoxification.	Participants assigned to this arm will receive a steady dose of buprenorphine for maintenance.
Measure Participants	5	5
Number [participants]	2 33.3%	4 66.7%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Tapering Doses of Buprenorphine, Steady Dose of Buprenorphine
	Comments	Intent to treat
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.523
	Comments
	Method	Fisher Exact
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.17
	Confidence Interval	() 95%; 0.0098 to 2.8215
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Number of Participants With Better Overall Quality of Life at Six Months as Compared to Baseline.
Description	Qualitative measure (better/no change/worse) of participant's perception of overall quality of life related to assigned study protocol arm.
Time Frame	Baseline and six months

Outcome Measure Data

Analysis Population Description

Reported value (number) was the number who reported a "better" overall quality-of-life to the question: "How would you describe your overall level of function now as compared to the time right before you started the study?" Responses were recorded as: "better," "no change," or "worse."

Arm/Group Title	Tapering Doses of Buprenorphine	Steady Dose of Buprenorphine
Arm/Group Description	Participants assigned to this arm will receive tapering doses of buprenorphine for detoxification.	Participants assigned to this arm will receive a steady dose of buprenorphine for maintenance.
Measure Participants	5	5
Number [Participants]	4 66.7%	4 66.7%

3. Secondary Outcome

Title	Treatment Retention.
Description	"Treatment retention" was defined as the completion of the buprenorphine dosing protocol (i.e., tapering doses vs. steady doses).
Time Frame	Six months

Outcome Measure Data

Analysis Population Description

Analysis was intent-to-treat.

Arm/Group Title	Tapering Doses of Buprenorphine	Steady Dose of Buprenorphine
Arm/Group Description	Participants assigned to this arm will receive tapering doses of buprenorphine for detoxification.	Participants assigned to this arm will receive a steady dose of buprenorphine for maintenance.
Measure Participants	6	6
Number [Participants]	0 0%	5 83.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Tapering Doses of Buprenorphine, Steady Dose of Buprenorphine
	Comments	Fisher exact test was used and tested the hypothesis that neither group would be more likely to complete the study protocol.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.015
	Comments	No adjustment
	Method	Fisher Exact
	Comments

Adverse Events

Arm/Group Title	Tapering Doses of Buprenorphine		Steady Dose of Buprenorphine
Arm/Group Description	Participants assigned to this arm will receive tapering doses of buprenorphine for detoxification.		Participants assigned to this arm will receive a steady dose of buprenorphine for maintenance.
All Cause Mortality
	Tapering Doses of Buprenorphine		Steady Dose of Buprenorphine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Tapering Doses of Buprenorphine		Steady Dose of Buprenorphine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/30 (0%)		0/30 (0%)
Other (Not Including Serious) Adverse Events
	Tapering Doses of Buprenorphine		Steady Dose of Buprenorphine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/30 (0%)		0/30 (0%)

Limitations/Caveats

[Not Specified]

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.