2015 Suboxone Treatment Presentation

By: Nellie Dennis

“EXTENDED VS. SHORT-TERM BUPRENORPHINE-

NALOXONEFOR TREATMENT OF

OPIOID-ADDICTED YOUTH”

-A RANDOMIZED TRIAL-

JAMA: Journal of the American Medical Association, Vol 300(17), Nov, 2008. pp. 2003-2011..

Opioid dependence—physical addiction to prescription painkillers and heroin—aff ects many people in the US.” ("Understanding opioid dependence", 2015)

“If you or someone you know may be dependent on opioids, you are not alone. In 2013, there were nearly 2.4 million reports of people † that had abused or were dependent on opioids—such as heroin—or prescription painkillers.” ("Understanding opioid dependence", 2015)

“Know your opioids: Opioids can be prescription painkillers. For example, Oxycodone, hydrocodone, and fentanyl—better known by the brand names as OxyContin ®, Vicodin®, Percocet®, and Actiq®—are opioids. The street drug heroin is also an opioid.” ("Understanding opioid dependence", 2015)

UNDERSTANDING OPIOID DEPENDENCE

Treats an addiction to or dependence on narcotic medicine.

Brand name: SuboxoneSide Effects:

Side effects of buprenorphine are similar to those of other opioids and include nausea, vomiting, and constipation. Buprenorphine/naloxone can precipitate the opioid withdrawal syndrome. Combination of: Naloxone, Buprenorphine ("Understanding opioid dependence", 2015)

Legal status: Schedule III controlled substance

Other drugs in same class: Buprenorphine, Naloxone, Naltrexone

WHAT IS BUPRENORPHINE-NALOXONE?

JAMA: Journal of the American Medical Association, Vol 300(17), Nov, 2008. pp.

2003-2011..


Buprenorphine/naloxone may cause drowsiness or dizziness. These eff ects may be worse if you take it with alcohol or certain medicines. Use buprenorphine/naloxone with caution. Do not drink alcohol while you are using buprenorphine/naloxone.

Buprenorphine/naloxone may cause dizziness, light-headedness, or fainting; alcohol, hot weather, exercise, or fever may increase these eff ects. Do NOT change your dose, use more often than prescribed, or suddenly stop taking buprenorphine/naloxone without checking with your doctor.

Do not switch to another dose form of buprenorphine/naloxone without talking to your doctor.

SAFETY INFORMATION


Many of you work/intern in the Chemical Dependency focus, just like myself; What are your views on the effectiveness of Suboxone

and/or detox?

QUESTION

http://www.google.com/url?sa=i&rct=j&q=&esrc=s&source=images&cd=&cad=rja&uact=8&ved=0CAcQjRw&url=http://mentalhealthtreatment.net/blog/pros-and-cons-of-suboxone-treatment-for-opiate-addiction/&ei=dswiVZnkCLWMsQSJpICQBw&bvm=bv.89947451,d.cWc&psig=AFQjCNHqWqUQwHD4X-jP3apGp8wnuc1MVQ&ust=1428430297054672


“To evaluate the effi cacy of continuing buprenorphine-naloxone for 12 weeks vs. detoxification for opioid-addicted youth.” (JAMA: Journal of the American Medical Association, Vol 300(17), Nov, 2008. pp. 2003-2011.)

“The usual treatment for opioid-addicted youth is short-term detoxification and individual or group therapy in residential or outpatient settings over weeks or months.” (JAMA: Journal of the American Medical Association, Vol 300(17), Nov, 2008. pp. 2003-2011.)

OBJECTIVE


Clinical trial at 6 community programs in the National Institute on Drug Abuse from July 2003 to December 2006.

152 patients aged 14 to 21 years

CASE STUDY DESIGN

All patients were randomized to 12 weeks of buprenorphine-naloxone (Suboxone) or a 14-day taper (Detox) between July, 2003 and December, 2005

“A biased-coin randomization protected against severe imbalance of sex, ethnicity, route of administration, and age across the treatment groups.” ( JAMA: Journal of the American Medical Association, Vol 300(17), Nov, 2008. pp. 2003-2011.)

ENROLLMENT AND RANDOMIZATION


2003-2011..

Reckitt Benckiser Pharmaceuticals Inc. provided medication, and the NIDA coordinated its distribution.

Day 1: First Dose: 2-mg. of Suboxone with 0.5-mg of naloxone. Second Dose: 2-6-mg was administered if appropriate.

Day 2: Received dose from day 1 unless considered over-

medicated or under-medicated. Dose adjusted by 2-6-mg as needed.

Day 3: Received dose from day 2 unless needed adjustment

MEDICATION AND DOSAGE


2003-2011..


Suboxone Group: Received a maximum amount of 24-mg per day and

began tapering at week 9 that would end by week 12!

Detox Group: Patients in the detox group received up to a maximum

amount of 14-mg buprenorphine per day and ended their taper by day 14.

MEDICATION AND DOSAGE


All patients were scheduled for 1 individual and 1 group session per week with more frequent sessions if needed!

Counseling Process: Making positive relationships Stopping the drug use Coping mechanisms throughout treatment Prescribed Medications Triggering situations Education on addiction Feedback on achieving personal goals Encouraging self-help meetings

DRUG COUNSELING


The primary outcome was opioid-positive urine test results at weeks 4, 8, 12. Urine samples were tested for adulteration (color, specific gravity, temperature)

Two tests were used: The Sure Step (Inverness Medical Innovations,

Bedford, England) that identifies amphetamine, barbiturate, benzodiazepines, cocaine, methadone, methamphetamine, morphine, hydrocodone, hydromorphone, oxycodone, phencyclidine, and tetrahydrocannabinol.

The second was the Rapid One OXY (American Bio Medica Corp, Kinderhook, New York), which is more sensitive to oxycodone.

PRIMARY OUTCOMES

Secondary outcomes were dropout from the assigned condition, self-reported use, injecting, enrollment in addiction treatment outside the assigned condition, other drug use, and adverse events.

Patients were considered drop outs if they missed medication for 3 consecutive days in the detox group or 7 consecutive days if in the 12 week suboxone group

Follow up visits as months 6, 9, and 23 included assessing self-reported use of opioids, alcohol, marijuana, and cocaine and injecting in the past month and determining whether patients were receiving other addiction treatment.

SECONDARY OUTCOMES


2003-2011..

Of 236 patients screened, 154 were randomized and n152 entered treatment.JAMA: Journal of the American Medical Association, Vol

300(17), Nov, 2008. pp. 2003-2011..


Among 78 Detox patients, 16 (20.5%) completed

Among 74 in the D12-week buprenorphine-naloxone group, 52 (70%) completed.

The most common reason for non completion was missing 2 weeks of counseling.

RESULTS


Months 6, 9, and 12 Patients in the detox group provided higher proportions of

positive urine test results than patients in the 12-week suboxone group.

Although high rates were seen in both groups: Suboxone: 48% Detox: 72%

There was a trend for fewer detox patients to be in other addiction treatment and for detox patients to have higher rates of marijuana use

The 2 groups did not differ in rates of self-reported use of alcohol.

POST-TREATMENT RESULTS


No serious adverse events attributable to suboxone were removed for adverse events

Headaches were the most common events reported by 16% to 21% of patients in both groups

Other symptoms of nausea, insomnia, stomachache, vomiting, anxiety were reported by less than 10%

One death occurred in a 19 year old patient in the suboxone group who dropped out.

COMMENTS


Short term vs long term addiction Young adult vs Adult

Suboxone patients are much more engaged in longer term treatment = better success?

COMMENTS


Small proportion of patients younger than 18 years

Almost total absence of young African American individuals

Frequent observed tox Good or Bad?

Low follow-up rate

Did not access adverse eff ects beyond 12 months

LIMITATIONS


Do you feel that this study is valid regardless of the limitations I have found?

Do you feel that Suboxone is an eff ective method after looking at this study?

How could this study improve, in your opinion?

QUESTIONS

Woody, G. (2003). “Extended vs. Short-term Buprenorphine-Naloxone for Treatment of Opioid-Addicted Youth”-A Randomized Trial-. 300(17), 2003-2011. Retrieved January 1, 2011, from PsycINFO.

Understanding opioid dependence. (2014, January 1). Retrieved April 7, 2015, from http://www.suboxone.com/understanding-opioid-dependence

REFERENCES

http://www.suboxone.com/understanding-opioid-dependence

http://www.suboxone.com/understanding-opioid-dependence

2015 Suboxone Treatment Presentation

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Transcript of 2015 Suboxone Treatment Presentation