A Preliminary, Open-Label Study of Naltrexone and Bupropion Combination Therapy for Treating Binge Drinking in Human Subjects

2019 ◽  
Author(s):  
T Jordan Walter ◽  
Montserrat Navarro ◽  
Todd E Thiele ◽  
Cort Pedersen ◽  
Alexey Kampov-Polevoy ◽  
...  
Keyword(s):  
Binge Drinking ◽  
Extended Release ◽  
Human Subjects ◽  
Open Label ◽  
Prospective Design ◽  
Open Label Study ◽  
Men And Women ◽  
Average Percentage ◽  
The Past ◽  
Preliminary Study

Abstract Aims The combination of bupropion and naltrexone has shown efficacy in reducing binge drinking in animal models. This study assessed the tolerability and potential utility of combined naltrexone and bupropion in reducing binge drinking in human subjects. Methods This preliminary study employed an open-label, single-arm, 12-week, prospective design. Twelve men and women who exhibited a minimum of five (men) or three (women) binge drinking episodes per month over the past 3 months were recruited. All subjects received both bupropion-extended release 300 mg/day and naltrexone 50 mg/day and were monitored throughout the 3-month treatment period. Binge drinking was assessed using the timeline follow-back method. Results Treatment with combined naltrexone and bupropion reduced the average number of drinks per binge drinking day from 7.8 drinks to 6.4 drinks and reduced the average percentage of binge drinking days per month from 19% (5.7 days/month) to 5% (1.5 days/month). Naltrexone and bupropion were generally well tolerated, with insomnia, headache and nausea/diarrhea being the most common side effects. Six subjects elected to stay on medication after the trial. Conclusions This study suggests that combined naltrexone and bupropion therapy should be further investigated for tolerability and efficacy in reducing binge drinking in humans.

scholarly journals An Open-Label Study of Doxazosin Extended-Release for PTSD: Findings and Recommendations for Future Research on Doxazosin

2018 ◽  
Vol 16 (1) ◽  
pp. 67-73 ◽  
Author(s):  
Anne Richards ◽  
Sabra Inslicht ◽  
Leslie Micaela Ruoff ◽  
Thomas James Metzler ◽  
Lizabeth Alexandra Goldstein ◽  
...  
Keyword(s):  
Extended Release ◽  
Future Research ◽  
Open Label ◽  
Open Label Study ◽  
Label Study

scholarly journals Innovative Approaches to Obtain Minors’ Consent for Biomedical HIV Prevention Trials: Multi-Site Quasi-Experimental Study of Adolescent and Parent Perspectives

10.2196/16509 ◽  
2020 ◽  
Vol 9 (3) ◽  
pp. e16509 ◽  
Author(s):  
Amelia Knopf ◽  
Mary A Ott ◽  
Claire Burke Draucker ◽  
J Dennis Fortenberry ◽  
Daniel H Reirden ◽  
...  
Keyword(s):  
Hiv Prevention ◽  
Parental Involvement ◽  
Human Subjects ◽  
Consent Process ◽  
Parental Consent ◽  
Open Label ◽  
Open Label Study ◽  
Biomedical Hiv Prevention ◽  
Quasi Experimental ◽  
Prevention Trials

Background Despite the high burden of new HIV infections in minor adolescents, they are often excluded from biomedical HIV prevention trials, largely owing to the ethical complexities of obtaining consent for enrollment. Researchers and ethics regulators have a duty to protect adolescents—as a special category of human subjects, they must have protection that extends beyond those afforded to all human subjects. Typically, additional protection includes parental consent for enrollment. However, parental consent can present a risk of harm for minor adolescents. Research involving minor adolescents indicate that they are unwilling to join biomedical trials for stigmatized health problems, such as HIV, when parental consent is required. This presents a significant barrier to progress in adolescent HIV prevention by creating delays in research and the translation of new scientific evidence generated in biomedical trials in adult populations. Objective This protocol aims to examine how parental involvement in the consent process affects the acceptability of hypothetical participation in biomedical HIV prevention trials from the perspectives of minor adolescents and parents of minor adolescents. Methods In this protocol, we use a quasi-experimental design that involves a simulated consent process for 2 different HIV prevention trials. The first trial is modeled after an open-label study of the use of tenofovir disoproxil fumarate and emtricitabine as preexposure prophylaxis for HIV. The second trial is modeled after a phase IIa trial of an injectable HIV integrase inhibitor. There are 2 groups in the study—minor adolescents aged 14 to 17 years, inclusive, and parents of minor adolescents in the same age range. The adolescent participants are randomized to 1 of 3 consent conditions with varying degrees of parental involvement. After undergoing a simulated consent process, they rate their willingness to participate (WTP) in each of the 2 trials if offered the opportunity. The primary outcome is WTP, given the consent condition. Parents undergo a similar process but are asked to rate the acceptability of each of the 3 consent conditions. The primary outcome is acceptability of the consent method for enrollment. The secondary outcomes include the following: capacity to consent among both participant groups, the prevalence of medical mistrust, and the effects of the study phase (eg, phase IIa vs the open-label study) and drug administration route (eg, oral vs injection) on WTP (adolescents) and acceptability (parents) of the consent method. Results Enrollment began in April 2018 and ended mid-September 2019. Data are being analyzed and dissemination is expected in April 2020. Conclusions The study will provide the needed empirical data about minor adolescents’ and parents’ perspectives on consent methods for minors. The evidence generated can be used to guide investigators and ethics regulators in the design of consent processes for biomedical HIV prevention trials. International Registered Report Identifier (IRRID) DERR1-10.2196/16509

Extended release levodopa at bedtime as a treatment for nocturiain Parkinson's disease: An open label study

2020 ◽  
Vol 410 ◽  
pp. 116625 ◽  
Author(s):  
Livia Brusa ◽  
Viviana Ponzo ◽  
Alessandro Stefani ◽  
Roberto Ceravolo ◽  
Giovanni Palermo ◽  
...  
Keyword(s):  
Parkinson’S Disease ◽  
Parkinson's Disease ◽  
Extended Release ◽  
Open Label ◽  
Open Label Study ◽  
Label Study

scholarly journals An Open-Label Study of Guanfacine Extended Release for Traumatic Stress Related Symptoms in Children and Adolescents

2013 ◽  
Vol 23 (4) ◽  
pp. 244-251 ◽  
Author(s):  
Daniel F. Connor ◽  
Damion J. Grasso ◽  
Michelle D. Slivinsky ◽  
Geraldine S. Pearson ◽  
Alok Banga
Keyword(s):  
Children And Adolescents ◽  
Traumatic Stress ◽  
Extended Release ◽  
Open Label ◽  
Open Label Study ◽  
Label Study

Subcutaneous or intravenous administration of romiplostim in thrombocytopenic patients with myelodysplastic syndrome (MDS)

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 7009-7009
Author(s):  
M. Sekeres ◽  
H. Kantarjian ◽  
P. Fenaux ◽  
P. Becker ◽  
A. Boruchov ◽  
...  
Keyword(s):  
Treatment Options ◽  
Open Label ◽  
Eligibility Criteria ◽  
Subcutaneous Injections ◽  
Open Label Study ◽  
Future Studies ◽  
Intravenous Injections ◽  
The Past ◽  
The Mean ◽  
Administration Schedules

7009 Background: Thrombocytopenia is common in patients (pts) with MDS, and treatment options are currently limited to platelet (plt) transfusions. Romiplostim is an Fc-peptide fusion protein (peptibody) that stimulates plt production by the same mechanism as thrombopoietin. Methods: This was a phase II, multicenter, single arm, open-label study. Eligibility criteria included IPSS low or intermediate-1 risk MDS and a mean baseline plt count ≤50x109/L. Safety and efficacy of romiplostim were evaluated in pts receiving 750μg romiplostim according to one of 3 schedules: weekly or biweekly subcutaneous injections (QWSC or Q2WSC), or biweekly intravenous injections (Q2WIV). Plt responses were measured per IWG 2006 criteria. Results: Of the 28 pts enrolled, 17 (61%) completed the study; 22 (79%) were male and the mean (±SD) baseline plt count was 29 (±10) x 109/L. The mean age was 71 years and 19 pts (68%) had received plt transfusions in the past year. Mean duration of exposure to romiplostim was 12 (±8) weeks. The most common adverse events (AEs) were fatigue and headache (both 18%). Five pts experienced serious AEs, and there were 2 cases of disease progression to AML: one pt in the QWSC cohort who received romiplostim for 4 weeks and one in the Q2WSC cohort who received romiplostim for 20 weeks. For pts who completed 8 weeks treatment, 15/23 (65%) achieved a plt response, defined by IWG 2006 criteria, and 14/23 (61%) did not require a plt transfusion during this period. The small number of pts limited the ability to compare administration schedules; minor differences were observed in plt responses and plt transfusions, and the incidence of AEs appeared similar among cohorts. Conclusions: IV and SC romiplostim appeared well-tolerated and effective in raising plt counts and avoiding plt transfusions in low and intermediate-1 risk MDS pts. The dose recommendation for future studies is 750μg, given QW or Q2W SC. [Table: see text] [Table: see text]

scholarly journals PMS30 EFFECTS OF 12-HOUR, EXTENDED-RELEASE HYDROCODONE/ACETAMINOPHEN ON PAIN-RELATED WORK PRODUCTIVITY: A SUBANALYSIS FROM A 56-WEEK OPEN-LABEL STUDY

2008 ◽  
Vol 11 (3) ◽  
pp. A263-A264
Author(s):  
D Webster ◽  
D Herrington ◽  
B Corser ◽  
R Rapoport ◽  
AH Dikranian ◽  
...  
Keyword(s):  
Extended Release ◽  
Work Productivity ◽  
Open Label ◽  
Open Label Study ◽  
Label Study

scholarly journals Open-label study of treatment with alendronate sodium plus vitamin D in men and women with osteoporosis in Thailand

2018 ◽  
Vol 19 (1) ◽  
Author(s):  
Thawee Songpatanasilp ◽  
Sattaya Rojanasthien ◽  
Pansak Sugkraroek ◽  
Boonsong Ongphiphadhanakul ◽  
Lamar Robert ◽  
...  
Keyword(s):  
Vitamin D ◽  
Alendronate Sodium ◽  
Open Label ◽  
Open Label Study ◽  
Men And Women ◽  
Label Study
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