SUBOXONE SUMMARY
SUBOXONE sublingual tablets contain buprenorphine HCl and naloxone HCl dihydrate at a ratio of 4:1 buprenorphine: naloxone (ratio of free bases).
SUBOXONE and SUBUTEX are indicated for the treatment of opioid dependence.
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NEWS HIGHLIGHTSMedia Articles Related to Suboxone (Buprenorphine / Naloxone)
Suboxone Maker Pulls Pills in Favor of Film
Source: MedPage Today Product Alert [2012.09.25]
The buprenorphine-naloxone combination product (Suboxone) in sublingual tablet form will soon be pulled from the U.S. market because its child-resistant packaging isn't effective enough.
Published Studies Related to Suboxone (Buprenorphine / Naloxone)
A prospective, randomized, multicenter acceptability and safety study of direct buprenorphine/naloxone induction in heroin-dependent individuals. [2011.07.12]
Aims To provide controlled data on direct induction with buprenorphine/naloxone (BNX) versus indirect buprenorphine (BPN)-to-BNX induction. Design Phase 4, prospective, randomized, active-drug controlled, parallel-group trial consisting of a 2-day, double-blind, double-dummy induction phase followed by 26 days of open-label treatment with BNX...
Induction of opioid-dependent individuals onto buprenorphine and buprenorphine/naloxone soluble-films. [2011.03]
A sublingual soluble-film formulation of buprenorphine/naloxone (B/N) has been approved by the US Food and Drug Administration for the treatment of opioid dependency...
The subjective, reinforcing, and analgesic effects of oxycodone in patients with chronic, non-malignant pain who are maintained on sublingual buprenorphine/naloxone. [2011.01]
Some sources suggest that significant misuse of opioid drugs exists among patients with chronic pain. However, the risk factors and motivation behind their abuse may differ from those of other opioid abusers... These data suggest that sublingual Bup/Nx has the potential as an analgesic medication and further research should investigate its use in treating patients with chronic pain who abuse opioids.
Induction of opioid-dependent individuals onto buprenorphine and
buprenorphine/naloxone soluble-films. [2011]
A sublingual soluble-film formulation of buprenorphine/naloxone (B/N) has been
approved by the US Food and Drug Administration for the treatment of opioid
dependency...
Cost-effectiveness of extended buprenorphine-naloxone treatment for opioid-dependent youth: data from a randomized trial. [2010.09]
AIMS: The objective is to estimate cost, net social cost and cost-effectiveness in a clinical trial of extended buprenorphine-naloxone (BUP) treatment versus brief detoxification treatment in opioid-dependent youth... CONCLUSIONS: Extended BUP treatment relative to brief detoxification is cost effective in the US health-care system for the outpatient treatment of opioid-dependent youth.
Clinical Trials Related to Suboxone (Buprenorphine / Naloxone)
Preference for Subutex® (Buprenorphine) Versus Suboxone® (Buprenorphin/Naloxone) in Opioid Dependent Patients on Subutex (Study P05094)(COMPLETED) [Completed]
This study is designed to determine if opioid dependent subjects who are already receiving
Subutex prefer the Suboxone tablet over the Subutex tablet after switching from Subutex to
Suboxone. Subjects who are selected to participate in this study will continue their
prescribed dose of Subutex (buprenorphin 2 to 16 mg daily) for the first two days of the
study (Day 1 and Day 2) then switch to and receive an equivalent dose of Suboxone
(buprenorphine 2 to 16 mg daily) for the last 3 days of the study (Day 3, Day 4 and Day 5).
The Day 5 Visit will be the subject's last study visit. Upon completing the study, subjects
will continue their pre-study prescribed dosage of Subutex.
Multicentre Trial of Suboxone in Opiate-dependent Subjects in Taiwan [Recruiting]
To determine whether Suboxone can be effectively used to treat Taiwanese ethnic subjects
with opiate dependence.
Acceptability and Safety of Switching From Subutex or Other Opioid Drug Dependence Therapy to Suboxone (Study P05444) [Recruiting]
The purpose of this study is to evaluate the acceptibility and safety of switching to
buprenorphine/naloxone (Suboxone®) and the effect of the switch on medication dispensing.
Subjects will initiate therapy on Day 1 of the study; dosage will be adjusted between Day 2
to 7. Data will be collected at the end of Weeks 2 and 4, then monthly up to the end of
Month 12.
Optimizing Outcomes Using Suboxone for Opiate Dependence [Recruiting]
Building on a platform of pharmacological treatment with Suboxone (buprenorphine and
naloxone), participants are randomly assigned to one of four psychosocial treatment
conditions.
HIV Risk Reduction in Subutex Injectors in Tbilisi [Not yet recruiting]
This study will obtain pilot data on the acceptability of a 12-week course of daily observed
suboxone and methadone, followed by a dose taper or referral to a local treatment program
for 80 opioid dependent patients (40 group) who have been injecting subutex or other
buprenorphine preparations 10 or more days in the past 30, and on the impact of each
medication on HIV risk and on subutex and opioid use during treatment and a followup at week
20. it will be done at the Uranti Methadone Program, affiliated with the Addiction Research
Center, Union Alternative of Georgia in Tbilisi.
Reports of Suspected Suboxone (Buprenorphine / Naloxone) Side Effects
Maternal Exposure During Pregnancy (128),
Drug Withdrawal Syndrome (101),
Foetal Exposure During Pregnancy (97),
Wrong Technique in Drug Usage Process (86),
Convulsion (69),
Substance Abuse (67),
Underdose (58),
Suicidal Ideation (57),
Pain (54),
Drug Withdrawal Syndrome Neonatal (49), more >>
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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 2 ratings/reviews, Suboxone has an overall score of 10. The effectiveness score is 10 and the side effect score is 8. The scores are on ten point scale: 10 - best, 1 - worst.
| | Suboxone review by 28 year old male patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Highly Effective |
| Side effects: | | Mild Side Effects | | |
Treatment Info |
| Condition / reason: | | Opioid Addiction |
| Dosage & duration: | | 8mg/2mg taken once a day in the a.m. for the period of Continue to take it |
| Other conditions: | | Depression, Anxiety |
| Other drugs taken: | | Cymbalta, Neurontin | | |
Reported Results |
| Benefits: | | Suboxone is beneficial for two reasons:
1) It eliminated the opiate withdrawal when I was kicking my original drug of choice.
2) As a maintenance drug, Suboxone eliminates the cravings that I would normally have for opioids, as well as blocks the effects of agonist opioids (Heroin, Oxycodone, etc.) so that there is no temptation to take these drugs.
Instead of struggling every day to avoid taking opioid drugs (and all of the terrible thing that come with being in active addiction) I can take Suboxone and move on with life.
Suboxone may have quite literally saved my life. |
| Side effects: | | My only major complaint is that since Suboxone is an opioid (though different from Heroin, Oxy, etc.) it causes constipation.
Due to Suboxone's opioid blocking effect, if pain medication were needed in a hospital emergency setting, there could be complications. If I came in to the ER with a broken arm and they gave me a shot of Morphine, it would do absolutely nothing. Though this hasn't been an issue for me yet. |
| Comments: | | I am a drug addict, and although I went to rehab to get off of opiate drugs I just couldn't seem to stop. So I went on Suboxone, which is a new alternative to Methadone treatment.
While Methadone is a normal agonist opioid ('agonist' means it gets use high) it can be dispensed to drug addicts to keep them from withdrawing from their drug of choice because the Methadone lasts so long. But Methadone must be taken every day at a clinic and cannot be taken home, addicts can STILL use drugs while on Methadone if they choose too, it is EXTREMELY difficult to get off of, and Methadone still gets users high.
Suboxone is a great alternative because it can be prescribed and bought at the pharmacy so you can take it at home, it takes care of your drug cravings but it doesn't get you high (not exactly, anyways, but it does satisfy the Opiate Receptors enough) and it's really not all THAT hard to get off of if you must (the withdrawals are are VERY manageable). |
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| | Suboxone review by 21 year old male patient | | | Rating |
| Overall rating: | | |
| Effectiveness: | | Highly Effective |
| Side effects: | | Mild Side Effects | | |
Treatment Info |
| Condition / reason: | | Opiate/Heroin Addiction |
| Dosage & duration: | | 16mg / day. taken 2x daily - 8mg am, 8mg pm. for the period of 1.5 yrs to Present |
| Other conditions: | | Depression |
| Other drugs taken: | | Past- celexa. Present- Wellbutrin. | | |
Reported Results |
| Benefits: | | Was able to successfully, and completely, discontinue illicit use of heroin/opiates. I did remain abstinent for a period of time w/o it, but no longer than 6-7 months. Always at or before that point I would wind up relapsing again, with no good outcomes. Have stayed opiate-free for 1 year, 9 months now, and continue suboxone treatment. |
| Side effects: | | Only negative(/side) effects noted are:
Don't take doses too close together - feel dehydrated, headaches, fatigued.
DO NOT neglect meeting w/prescribing physician for writing of next script. Ive had to miss 2+ appts before, and have gone b/t 1-6 days w/o medication. I HIGHLY SUGGEST TO AVOID THAT. |
| Comments: | | I initially started at 4mg (/half 8mg tablet) 1x in am. Gradually rose to 1 8mg tablet 1x in am, and then 2 8mg tablets 1x in am. I found that, as said above, if i took doses too close together (ex: Noon on Sunday, then 4am Monday), would feel odd, off, and very drained. So now i take 1 8mg tab in am, and 1 8mg tab in pm. Found to be very effective and feel very 'steady' and 'even' throughout the day, and night. No issues with taking am/pm's too close together, or far apart.
Also go to group & individual counseling, and see psychotherapist (as well as intermittent AA/NA meetings) to stay active in Recovery and stay healthy and well, all around. Also do the aforementioned to stay on top of depression and anxiety as well as reg life issues. |
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Page last updated: 2013-02-10
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