naltrexone

This database study examines the association between glucagon-like peptide 1 agonists (eg, semaglutide, liraglutide) used for weight loss and reports of gastrointestinal adverse events.

Author/s:

Mohit Sodhi, Ramin Rezaeianzadeh, Abbas Kezouh, Mahyar Etminan

Bupropion and Naltrexone in Methamphetamine Use Disorder

Devin Evans — Thu, 21 Jan 2021 06:00:00 +0000

Date Added:

January 21, 2021

Journal/Publication:

The New England Journal of Medicine

Publication Date:

January 14, 2021

Volume:

384

Pages:

140-153

URL:

Bupropion and Naltrexone in Methamphetamine Use Disorder

Type:

Clinical Research Results

Format:

Article

DOI (1):

10.1056/NEJMoa2020214

Keywords

Methamphetamine Use Disorder

MeSH

The combination of extended-release injectable naltrexone (380 mg every 3 weeks) plus oral extended-release bupropion (450 mg per day) was more effective than placebo for helping adults abstain from methamphetamine. James W. Mold, MD, MPH

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BACKGROUND

The use of naltrexone plus bupropion to treat methamphetamine use disorder has not been well studied.

METHODS

We conducted this multisite, double-blind, two-stage, placebo-controlled trial with the use of a sequential parallel comparison design to evaluate the efficacy and safety of extended-release injectable naltrexone (380 mg every 3 weeks) plus oral extended-release bupropion (450 mg per day) in adults with moderate or severe methamphetamine use disorder. In the first stage of the trial, participants were randomly assigned in a 0.26:0.74 ratio to receive naltrexone–bupropion or matching injectable and oral placebo for 6 weeks. Those in the placebo group who did not have a response in stage 1 underwent rerandomization in stage 2 and were assigned in a 1:1 ratio to receive naltrexone–bupropion or placebo for an additional 6 weeks. Urine samples were obtained from participants twice weekly. The primary outcome was a response, defined as at least three methamphetamine-negative urine samples out of four samples obtained at the end of stage 1 or stage 2, and the weighted average of the responses in the two stages is reported. The treatment effect was defined as the between-group difference in the overall weighted responses.

RESULTS

A total of 403 participants were enrolled in stage 1, and 225 in stage 2. In the first stage, 18 of 109 participants (16.5%) in the naltrexone–bupropion group and 10 of 294 (3.4%) in the placebo group had a response. In the second stage, 13 of 114 (11.4%) in the naltrexone–bupropion group and 2 of 111 (1.8%) in the placebo group had a response. The weighted average response across the two stages was 13.6% with naltrexone–bupropion and 2.5% with placebo, for an overall treatment effect of 11.1 percentage points (Wald z-test statistic, 4.53; P<0.001). Adverse events with naltrexone–bupropion included gastrointestinal disorders, tremor, malaise, hyperhidrosis, and anorexia. Serious adverse events occurred in 8 of 223 participants (3.6%) who received naltrexone–bupropion during the trial.

CONCLUSIONS

Among adults with methamphetamine use disorder, the response over a period of 12 weeks among participants who received extended-release injectable naltrexone plus oral extended-release bupropion was low but was higher than that among participants who received placebo.

Author/s:

Trivedi, Madhukar H., Walker, Robrina, Ling, Walter, Dela Cruz, Adriane, Sharma, Gaurav, Carmody, Thomas, Ghitza, Udi E., Wahle, Aimee, Kim, Mora, Shores-Wilson, Kathy, Sparenborg, Steven, Coffin, Philip, Schmitz, Joy, Wiest, Katharina, Bart, Gavin, Sonne, Susan C., Wakhlu, Sidarth, Rush, A.J., Nunes, Edward V., Shoptaw, Steven

Evidenced-Based Pharmacotherapies for Alcohol Use Disorder

John Bayhi — Thu, 21 May 2020 16:22:32 +0000

Date Added:

May 21, 2020

Journal/Publication:

Mayo Clinic Proceedings

Publisher:

Elsevier Inc / Mayo Foundation for Medical Education and Research

Publication Date:

May 20, 2020

Volume:

Article in Press

URL:

Evidenced-Based Pharmacotherapies for Alcohol Use Disorder

Type:

Meta-analyses, Reviews, and Guidelines

Format:

Article

DOI (1):

10.1016/j.mayocp.2020.01.030

Keywords

MeSH

Pharmacogenomic Testing

united states food and drug administration

A review of pharmacological approaches to the treatment of alcoholism with some clinical pearls from Mayo physicians. James W. Mold, MD, MPH

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Pathologic alcohol use affects more than 2 billion people and accounts for nearly 6% of all deaths worldwide. There are three medications approved for the treatment of alcohol use disorder by the US Food and Drug Administration (FDA): disulfiram, naltrexone (oral and long-acting injectable), and acamprosate. Of growing interest is the use of anticonvulsants for the treatment of alcohol use disorder, although currently none are FDA approved for this indication. Baclofen, a γ-aminobutyric acid B receptor agonist used for spasticity and pain, received temporary approval for alcohol use disorder in France. Despite effective pharmacotherapies, less than 9% of patients who undergo any form of alcohol use disorder treatment receive pharmacotherapies. Current evidence does not support the use of pharmacogenetic testing for treatment individualization. The objective of this review is to provide knowledge on practice parameters for evidenced-based pharmacologic treatment approaches in patients with alcohol use disorder.

Author/s:

Fairbanks, J, Umbreit, A, Kolla, BP, Karpyak, VM, Schneekloth, TD, Loukianova, LL, Sinha, S

Comparative Effectiveness of Different Treatment Pathways for Opioid Use Disorder

John Bayhi — Fri, 07 Feb 2020 13:59:45 +0000

Date Added:

February 7, 2020

Journal/Publication:

JAMA Network Open

Publisher:

American Medical Association

Publication Date:

February 5, 2020

Issue:

Volume:

Pages:

e1920622

URL:

Comparative Effectiveness of Different Treatment Pathways for Opioid Use Disorder

Type:

Clinical Research Results

Format:

Article

DOI (1):

10.1001/jamanetworkopen.2019.20622

Keywords

PMID (1):

32022884

MeSH

retrospective studies

Inpatients

outpatients

Comparative Effectiveness Research

opioid-related disorders

If the goal is to reduce overdoses and ED visits, the best treatment options appear to include buprenorphine or methadone. James W. Mold, MD, MPH

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IMPORTANCE:

Although clinical trials demonstrate the superior effectiveness of medication for opioid use disorder (MOUD) compared with nonpharmacologic treatment, national data on the comparative effectiveness of real-world treatment pathways are lacking.

OBJECTIVE:

To examine associations between opioid use disorder (OUD) treatment pathways and overdose and opioid-related acute care use as proxies for OUD recurrence.

DESIGN, SETTING, AND PARTICIPANTS:

This retrospective comparative effectiveness research study assessed deidentified claims from the OptumLabs Data Warehouse from individuals aged 16 years or older with OUD and commercial or Medicare Advantage coverage. Opioid use disorder was identified based on 1 or more inpatient or 2 or more outpatient claims for OUD diagnosis codes within 3 months of each other; 1 or more claims for OUD plus diagnosis codes for opioid-related overdose, injection-related infection, or inpatient detoxification or residential services; or MOUD claims between January 1, 2015, and September 30, 2017. Data analysis was performed from April 1, 2018, to June 30, 2019.

EXPOSURES:

One of 6 mutually exclusive treatment pathways, including (1) no treatment, (2) inpatient detoxification or residential services, (3) intensive behavioral health, (4) buprenorphine or methadone, (5) naltrexone, and (6) nonintensive behavioral health.

MAIN OUTCOMES AND MEASURES:

Opioid-related overdose or serious acute care use during 3 and 12 months after initial treatment.

RESULTS:

A total of 40 885 individuals with OUD (mean [SD] age, 47.73 [17.25] years; 22 172 [54.2%] male; 30 332 [74.2%] white) were identified. For OUD treatment, 24 258 (59.3%) received nonintensive behavioral health, 6455 (15.8%) received inpatient detoxification or residential services, 5123 (12.5%) received MOUD treatment with buprenorphine or methadone, 1970 (4.8%) received intensive behavioral health, and 963 (2.4%) received MOUD treatment with naltrexone. During 3-month follow-up, 707 participants (1.7%) experienced an overdose, and 773 (1.9%) had serious opioid-related acute care use. Only treatment with buprenorphine or methadone was associated with a reduced risk of overdose during 3-month (adjusted hazard ratio [AHR], 0.24; 95% CI, 0.14-0.41) and 12-month (AHR, 0.41; 95% CI, 0.31-0.55) follow-up. Treatment with buprenorphine or methadone was also associated with reduction in serious opioid-related acute care use during 3-month (AHR, 0.68; 95% CI, 0.47-0.99) and 12-month (AHR, 0.74; 95% CI, 0.58-0.95) follow-up.

CONCLUSIONS AND RELEVANCE:

Treatment with buprenorphine or methadone was associated with reductions in overdose and serious opioid-related acute care use compared with other treatments. Strategies to address the underuse of MOUD are needed.

Author/s:

Wakeman, SE, Larochelle, MR, Ameli, O, Chaisson, CE, McPheeters, JT, Crown, WH, Azocar, F, Sanghavi, DM

Medication-Assisted Treatment for Opioid-Use Disorder

John Bayhi — Tue, 24 Sep 2019 22:22:30 +0000

Date Added:

October 3, 2019

Journal/Publication:

Mayo Clinic Proceedings

Publisher:

Mayo Foundation for Medical Education and Research / Elsevier Inc.

Publication Date:

September 9, 2019

Issue:

Volume:

Pages:

2072-2086

URL:

Medication-Assisted Treatment for Opioid-Use Disorder

Type:

Meta-analyses, Reviews, and Guidelines

Format:

Article

DOI (1):

10.1016/j.mayocp.2019.03.029

Keywords

PMID (1):

31543255

MeSH

Buprenorphine

naltrexone

methadone

opioid-related disorders

analgesics, opioid

outpatients

A nice review of how and when to use the three available medications for treating patients with opioid dependency. James W. Mold, MD, MPH

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The United States is in the midst of a national opioid epidemic. Physicians are encouraged both to prevent and treat opioid-use disorders (OUDs). Although there are 3 Food and Drug Administration-approved medications to treat OUD (methadone, buprenorphine, and naltrexone) and there is ample evidence of their efficacy, they are not used as often as they should. We provide a brief review of the 3 primary medications used in the treatment of OUD. Using data from available medical literature, we synthesize existing knowledge and provide a framework for how to determine the optimal approach for outpatient management of OUD with medication-assisted treatments.

Author/s:

Oesterle, TS, Thusius, NJ, Rummans, TA, Gold, MS

Naltrexone for the treatment of alcoholism: A meta-analysis of randomized controlled trials

Jeffrey Wilson — Wed, 02 Jan 2019 14:38:22 +0000

Date Added:

January 2, 2019

Journal/Publication:

International Journal of Neuropsychopharmacology

Publisher:

Oxford University Press

Publication Date:

June 1, 2005

Issue:

Volume:

Pages:

267-280

URL:

Naltrexone for the treatment of alcoholism: A meta-analysis of randomized controlled trials

Type:

Meta-analyses, Reviews, and Guidelines

Format:

Article

DOI (1):

10.1017/S1461145704004997

Keywords

alcohol

alcoholism

naltrexone

PMID (1):

15850502

MeSH

alcohol

alcoholism

naltrexone

This Meta-analysis involving 2861 subjects in 24 RCTs found that, in short-term treatment, naltrexone significantly decreased relapses [relative risk (RR) 0.64, 95% confidence interval (CI) 0.51-0.82], but not return to drinking (RR 0.91, 95% CI 0.81-1.02). Short-term treatment of naltrexone significantly increased nausea, dizziness, and fatigue in comparison to placebo [RRs (95% CIs) 2.14 (1.61-2.83), 2.09 (1.28-3.39), and 1.35 (1.04-1.75)].

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Many trials of naltrexone have been carried out in alcohol-dependent patients. This paper is aimed to systematically review its benefits, adverse effects, and discontinuation of treatment. We assessed and extracted the data of double-blind, randomized controlled trials (RCTs) comparing naltrexone with placebo or other treatment in people with alcoholism. Two primary outcomes were subjects who relapsed (including heavy drinking) and those who returned to drinking. Secondary outcomes were time to first drink, drinking days, number of standard drinks for a defined period, and craving. All outcomes were reported for the short, medium, and long term. Five common adverse effects and dropout rates in short-term treatment were also examined. A total of 2861 subjects in 24 RCTs presented in 32 papers were included. For short-term treatment, naltrexone significantly decreased relapses [relative risk (RR) 0.64, 95% confidence interval (CI) 0.51-0.82], but not return to drinking (RR 0.91, 95% CI 0.81-1.02). Short-term treatment of naltrexone significantly increased nausea, dizziness, and fatigue in comparison to placebo [RRs (95% CIs) 2.14 (1.61-2.83), 2.09 (1.28-3.39), and 1.35 (1.04-1.75)]. Naltrexone administration did not significantly diminish short-term discontinuation of treatment (RR 0.85, 95% CI 0.70-1.01). Naltrexone should be accepted as a short-term treatment for alcoholism. As yet, we do not know the appropriate duration of treatment continuation in an alcohol-dependent patient who responds to short-term naltrexone administration. To ensure that the real-world treatment is as effective as the research findings, a form of psychosocial therapy should be concomitantly given to all alcohol-dependent patients receiving naltrexone administration.

Author/s:

Srisurapanont, Manit, Jarusuraisin, Ngamwong

Diagnosis and Pharmacotherapy of Alcohol Use Disorder: A Review

Jeffrey Wilson — Thu, 27 Dec 2018 16:24:11 +0000

Date Added:

December 27, 2018

Journal/Publication:

JAMA

Publisher:

American Medical Association

Publication Date:

August 28, 2018

Issue:

Volume:

320

Pages:

815-824

URL:

Diagnosis and Pharmacotherapy of Alcohol Use Disorder: A Review

Type:

Meta-analyses, Reviews, and Guidelines

Format:

Article

DOI (1):

10.1001/jama.2018.11406

Keywords

alcohol

alcoholism

pharmacogenetics

PMID (1):

30167705

MeSH

This is a 5-part series of reviews pertaining to the treatment of patients with alcohol use disorders.

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IMPORTANCE:

Alcohol consumption is associated with 88 000 US deaths annually. Although routine screening for heavy alcohol use can identify patients with alcohol use disorder (AUD) and has been recommended, only 1 in 6 US adults report ever having been asked by a health professional about their drinking behavior. Alcohol use disorder, a problematic pattern of alcohol use accompanied by clinically significant impairment or distress, is present in up to 14% of US adults during a 1-year period, although only about 8% of affected individuals are treated in an alcohol treatment facility.

OBSERVATIONS:

Four medications are approved by the US Food and Drug Administration to treat AUD: disulfiram, naltrexone (oral and long-acting injectable formulations), and acamprosate. However, patients with AUD most commonly receive counseling. Medications are prescribed to less than 9% of patients who are likely to benefit from them, given evidence that they exert clinically meaningful effects and their inclusion in clinical practice guidelines as first-line treatments for moderate to severe AUD. Naltrexone, which can be given once daily, reduces the likelihood of a return to any drinking by 5% and binge-drinking risk by 10%. Randomized clinical trials also show that some medications approved for other indications, including seizure disorder (eg, topiramate), are efficacious in treating AUD. Currently, there is not sufficient evidence to support the use of pharmacogenetics to personalize AUD treatments.

CONCLUSIONS AND RELEVANCE:

Alcohol consumption is associated with a high rate of morbidity and mortality, and heavy alcohol use is the major risk factor for AUD. Simple, valid screening methods can be used to identify patients with heavy alcohol use, who can then be evaluated for the presence of an AUD. Patients receiving a diagnosis of the disorder should be given brief counseling and prescribed a first-line medication (eg, naltrexone) or referred for a more intensive psychosocial intervention.

Author/s:

Kranzler, Henry R., Soyka, Michael