Worries About Discontinuing Buprenorphine Treatment: Scale Development and Clinical Correlates.
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ABSTRACT: Background and objectives
Despite the benefits of maintenance buprenorphine treatment for opioid use disorder (OUD), many individuals report an interest in discontinuing the medication, while also expressing worries about tapering. The purpose of this study was to develop a measure of worries about buprenorphine discontinuation ("Off Bupe") and determine the demographic and clinical characteristics associated with these worries.Methods
Between May 2017 and May 2018, we surveyed adults in an outpatient primary care buprenorphine program (n = 138). Reliability and validity of the Off Bupe measure were examined.Results
Participants averaged 39 years of age, 54% were male, average duration of buprenorphine was 189 weeks and 85.5% reported eventually wanting to discontinue buprenorphine, although fewer than 10% were actively tapering. We derived two scales, withdrawal symptom worry (10 items, ɑ = 0.94) and relapse worry (7 items, ɑ = 0.88). Worry about symptoms was positively associated with current buprenorphine dose (P = 0.016), physical discomfort avoidance (P < 0.001), and inversely associated with self-efficacy to quit buprenorphine (P < 0.001) and distress tolerance (P < 0.001). Worry about opioid relapse was associated positively with age (P = 0.019), current buprenorphine dose (P = 0.004), physical discomfort avoidance (P < 0.001), and impulsivity (P = 0.002), and inversely associated with self-efficacy to quit buprenorphine (P < 0.001).Discussion and conclusions
Psychometric evaluation of the "Off Bupe" scale demonstrated its content and construct validity and internal reliability.Scientific significance
The scale might help individuals with OUD and their providers identify concerns about discontinuing buprenorphine. (Am J Addict 2019;28:270-276).
SUBMITTER: Stein MD
PROVIDER: S-EPMC6591066 | biostudies-literature | 2019 Jul
REPOSITORIES: biostudies-literature
Publications
Worries About Discontinuing Buprenorphine Treatment: Scale Development and Clinical Correlates.
Stein Michael D MD Conti Micah T MT Herman Debra S DS Anderson Bradley J BJ Bailey Genie L GL Noppen Donnell Van DV Abrantes Ana M AM
The American journal on addictions 20190416 4
<h4>Background and objectives</h4>Despite the benefits of maintenance buprenorphine treatment for opioid use disorder (OUD), many individuals report an interest in discontinuing the medication, while also expressing worries about tapering. The purpose of this study was to develop a measure of worries about buprenorphine discontinuation ("Off Bupe") and determine the demographic and clinical characteristics associated with these worries.<h4>Methods</h4>Between May 2017 and May 2018, we surveyed a ...[more]
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Project description:Objectives: How individuals perceive the risk of COVID-19 influences their mental health and protective behaviors. Therefore, the development of an instrument to capture COVID-19-related worries and fears is relevant. This study aims to develop and validate the CoV-WoFe to measure COVID-19-related worries and fears. Methods: An online questionnaire was completed by 593 participants during Christmas 2020 and by 328 participants during Summer 2021, from which 88 participants formed a longitudinal sample. Results: Analyses confirmed a robust adjustment for consistency over time and a gender-invariant bifactorial structure. Factor 1 represented worry about the health consequences of COVID-19 and Factor 2 represented the perceived physiological symptoms associated with fear of COVID-19. Construct validity was evidenced by: the expected relations between the CoV-WoFe and other theoretically related constructs; the serial mediating role of both dimensions in the relationship that security values establish with protective behaviors against COVID-19 and with anxiety; and the expected gender differences in the Cov-WoFe. Conclusion: The CoV-WoFe represents a short, valid, reliable, gender-invariant tool that is easy to apply in both the health professional and research context to assessCOVID-19-related worries and fears, which are variables of relevance for spread of the virus and for mental health.
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Project description:BackgroundGestational opioid use/misuse is escalating in the United States; however, little is understood about the fetal effects of medications used to treat maternal opioid use disorders.ObjectiveThe purpose of this study was to determine the effect of maternal buprenorphine administration on longitudinal fetal neurobehavioral development.Study designForty-nine buprenorphine-maintained women who attended a substance use disorder treatment facility with generally uncomplicated pregnancies underwent fetal monitoring for 60 minutes at times of trough and peak maternal buprenorphine levels. Data were collected at 24, 28, 32, and 36 weeks gestation. Fetal neurobehavioral indicators (ie, heart rate, motor activity, and their integration [fetal movement-fetal heart rate coupling]) were collected via an actocardiograph, digitized and quantified. Longitudinal data analysis relied on hierarchic linear modeling.ResultsFetal heart rate, heart rate variability, and heart rate accelerations were significantly reduced at peak vs trough maternal buprenorphine levels. Effects were significant either by or after 28 weeks gestation and tended to intensify with advancing gestation. Fetal motor activity and fetal movement-fetal heart rate coupling were depressed from peak to trough at 36 weeks gestation. Polysubstance exposure did not significantly affect fetal neurobehavioral parameters, with the exception that fetuses of heavier smokers moved significantly less than those of lighter smokers at 36 weeks gestation. By the end of gestation, higher maternal buprenorphine dose was related to depression of baseline fetal cardiac measures at trough.ConclusionMaternal buprenorphine administration has acute suppressive effects on fetal heart rate and movement, and the magnitude of these effects increases as gestation progresses. Higher dose (≥13 mg) appears to exert greater depressive effects on measures of fetal heart rate and variability. These findings should be balanced against comparisons to gestational methadone effects, relatively good outcomes of buprenorphine-exposed infants, and recognition of the benefits of medication-assisted treatment for pregnant women with opioid use disorders in optimizing pregnancy outcomes.
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Project description:Despite the benefits associated with longer buprenorphine treatment duration (i.e., >180 days) (BTD) for opioid use disorder (OUD), retention remains poor. Research on the impact of co-occurring psychiatric issues on BTD has yielded mixed results. It is also unknown whether the genetic risk in the form of polygenic scores (PGS) for OUD and other comorbid conditions, including problematic alcohol use (PAU) are associated with BTD. We tested the association between somatic and psychiatric comorbidities and long BTD and determined whether PGS for OUD-related conditions was associated with BTD. The study included 6686 individuals with a buprenorphine prescription that lasted for less than 6 months (short-BTD) and 1282 individuals with a buprenorphine prescription that lasted for at least 6 months (long-BTD). Recorded diagnosis of substance addiction and disorders (Odds Ratio (95% CI) = 22.14 (21.88-22.41), P = 2.8 × 10-116), tobacco use disorder (OR (95% CI) = 23.4 (23.13-23.68), P = 4.5 × 10-111), and bipolar disorder (OR(95% CI) = 9.70 (9.48-9.92), P = 1.3 × 10-91), among others, were associated with longer BTD. The PGS of OUD and several OUD co-morbid conditions were associated with any buprenorphine prescription. A higher PGS for OUD (OR per SD increase in PGS (95%CI) = 1.43(1.16-1.77), P = 0.0009), loneliness (OR(95% CI) = 1.39(1.13-1.72), P = 0.002), problematic alcohol use (OR(95%CI) = 1.47(1.19-1.83), P = 0.0004), and externalizing disorders (OR(95%CI) = 1.52(1.23 to 1.89), P = 0.0001) was significantly associated with long-BTD. Associations between BTD and the PGS of depression, chronic pain, nicotine dependence, cannabis use disorder, and bipolar disorder did not survive correction for multiple testing. Longer BTD is associated with diagnoses of psychiatric and somatic conditions in the EHR, as is the genetic score for OUD, loneliness, problematic alcohol use, and externalizing disorders.
| S-EPMC10781771 | biostudies-literature
Project description:ImportanceBuprenorphine opioid agonist treatment (OAT) has established efficacy for treating opioid dependency among persons seeking addiction treatment. However, effectiveness for out-of-treatment, hospitalized patients is not known.ObjectiveTo determine whether buprenorphine administration during medical hospitalization and linkage to office-based buprenorphine OAT after discharge increase entry into office-based OAT, increase sustained engagement in OAT, and decrease illicit opioid use at 6 months after hospitalization.Design, setting, and participantsFrom August 1, 2009, through October 31, 2012, a total of 663 hospitalized, opioid-dependent patients in a general medical hospital were identified. Of these, 369 did not meet eligibility criteria. A total of 145 eligible patients consented to participation in the randomized clinical trial. Of these, 139 completed the baseline interview and were assigned to the detoxification (n = 67) or linkage (n = 72) group.InterventionsFive-day buprenorphine detoxification protocol or buprenorphine induction, intrahospital dose stabilization, and postdischarge transition to maintenance buprenorphine OAT affiliated with the hospital's primary care clinic (linkage).Main outcomes and measuresEntry and sustained engagement with buprenorphine OAT at 1, 3, and 6 months (medical record verified) and prior 30-day use of illicit opioids (self-report).ResultsDuring follow-up, linkage participants were more likely to enter buprenorphine OAT than those in the detoxification group (52 [72.2%] vs 8 [11.9%], P < .001). At 6 months, 12 linkage participants (16.7%) and 2 detoxification participants (3.0%) were receiving buprenorphine OAT (P = .007). Compared with those in the detoxification group, participants randomized to the linkage group reported less illicit opioid use in the 30 days before the 6-month interview (incidence rate ratio, 0.60; 95% CI, 0.46-0.73; P < .01) in an intent-to-treat analysis.Conclusions and relevanceCompared with an inpatient detoxification protocol, initiation of and linkage to buprenorphine treatment is an effective means for engaging medically hospitalized patients who are not seeking addiction treatment and reduces illicit opioid use 6 months after hospitalization. However, maintaining engagement in treatment remains a challenge.Trial registrationclinicaltrials.gov Identifier: NCT00987961.
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Project description:ImportanceExpansion of opioid use disorder treatment is needed, particularly in rural communities.ObjectiveTo evaluate technology-assisted buprenorphine (TAB) efficacy (1) over a longer period than previously examined, (2) with the addition of overdose education, and (3) among individuals residing in rural communities.Design, setting, and participantsTwo parallel, 24-week randomized clinical trials were conducted at the University of Vermont between February 1, 2018, and June 30, 2022. Participants were adults with untreated opioid use disorder from nonrural (trial 1) or rural (trial 2) communities. These trials are part of a programmatic effort to develop TAB protocols to improve treatment availability in underserved areas.InterventionsWithin each trial, 50 participants were randomized to TAB or control conditions. Participants in the TAB group completed bimonthly visits to ingest medication and receive take-home doses via a computerized device. They received nightly calls via an interactive voice response (IVR) system, IVR-generated random call-backs, and iPad-delivered HIV, hepatitis C virus (HCV), and overdose education. Control participants received community resource guides and assistance with contacting resources. All participants received harm reduction supplies and completed monthly assessments.Main outcomes and measuresThe primary outcome was biochemically verified illicit opioid abstinence across monthly assessments. Secondary outcomes included self-reported opioid use in both groups and abstinence at bimonthly and random call-back visits, treatment adherence, satisfaction, and changes in HIV, HCV, and overdose knowledge among TAB participants.ResultsFifty individuals (mean [SD] age, 40.6 [13.1] years; 28 [56.0%] male) participated in trial 1, and 50 (mean [SD] age, 40.3 [10.8] years; 30 [60.0%] male) participated in trial 2. Participants in the TAB group achieved significantly greater illicit opioid abstinence vs controls at all time points in both trial 1 (85.3% [128 of 150]; 95% CI, 70.7%-93.3%; vs 24.0% [36 of 150]; 95% CI, 13.6%-38.8%) and trial 2 (88.0% [132 of 150]; 95% CI, 72.1%-95.4%; vs 21.3% [32 of 150]; 95% CI, 11.4%-36.5%). High abstinence rates were also observed at TAB participants' bimonthly dosing visits (83.0% [95% CI, 67.0%-92.0%] for trial 1 and 88.0% [95% CI, 71.0%-95.0%] for trial 2). Treatment adherence was favorable and similar between trials (with rates of approximately 99% for buprenorphine administration, 93% for daily IVR calls, and 92% for random call-backs), and 183 of 187 urine samples (97.9%) tested negative for illicit opioids at random call-backs. iPad-delivered education was associated with significant and sustained increases in HIV, HCV, and overdose knowledge.Conclusions and relevanceIn these randomized clinical trials of TAB treatment, demonstration of efficacy was extended to a longer duration than previously examined and to patients residing in rural communities.Trial registrationClinicalTrials.gov Identifier: NCT03420313.
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Project description:ImportanceOpioid-dependent patients often use the emergency department (ED) for medical care.ObjectiveTo test the efficacy of 3 interventions for opioid dependence: (1) screening and referral to treatment (referral); (2) screening, brief intervention, and facilitated referral to community-based treatment services (brief intervention); and (3) screening, brief intervention, ED-initiated treatment with buprenorphine/naloxone, and referral to primary care for 10-week follow-up (buprenorphine).Design, setting, and participantsA randomized clinical trial involving 329 opioid-dependent patients who were treated at an urban teaching hospital ED from April 7, 2009, through June 25, 2013.InterventionsAfter screening, 104 patients were randomized to the referral group, 111 to the brief intervention group, and 114 to the buprenorphine treatment group.Main outcomes and measuresEnrollment in and receiving addiction treatment 30 days after randomization was the primary outcome. Self-reported days of illicit opioid use, urine testing for illicit opioids, human immunodeficiency virus (HIV) risk, and use of addiction treatment services were the secondary outcomes.ResultsSeventy-eight percent of patients in the buprenorphine group (89 of 114 [95% CI, 70%-85%]) vs 37% in the referral group (38 of 102 [95% CI, 28%-47%]) and 45% in the brief intervention group (50 of 111 [95% CI, 36%-54%]) were engaged in addiction treatment on the 30th day after randomization (P < .001). The buprenorphine group reduced the number of days of illicit opioid use per week from 5.4 days (95% CI, 5.1-5.7) to 0.9 days (95% CI, 0.5-1.3) vs a reduction from 5.4 days (95% CI, 5.1-5.7) to 2.3 days (95% CI, 1.7-3.0) in the referral group and from 5.6 days (95% CI, 5.3-5.9) to 2.4 days (95% CI, 1.8-3.0) in the brief intervention group (P < .001 for both time and intervention effects; P = .02 for the interaction effect). The rates of urine samples that tested negative for opioids did not differ statistically across groups, with 53.8% (95% CI, 42%-65%) in the referral group, 42.9% (95% CI, 31%-55%) in the brief intervention group, and 57.6% (95% CI, 47%-68%) in the buprenorphine group (P = .17). There were no statistically significant differences in HIV risk across groups (P = .66). Eleven percent of patients in the buprenorphine group (95% CI, 6%-19%) used inpatient addiction treatment services, whereas 37% in the referral group (95% CI, 27%-48%) and 35% in the brief intervention group (95% CI, 25%-37%) used inpatient addiction treatment services (P < .001).Conclusions and relevanceAmong opioid-dependent patients, ED-initiated buprenorphine treatment vs brief intervention and referral significantly increased engagement in addiction treatment, reduced self-reported illicit opioid use, and decreased use of inpatient addiction treatment services but did not significantly decrease the rates of urine samples that tested positive for opioids or of HIV risk. These findings require replication in other centers before widespread adoption.Trial registrationclinicaltrials.gov Identifier: NCT00913770.
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Project description:ImportanceBuprenorphine treatment for opioid use disorder may be improved by sustained-release formulations.ObjectiveTo determine whether treatment involving novel weekly and monthly subcutaneous (SC) buprenorphine depot formulations is noninferior to a daily sublingual (SL) combination of buprenorphine hydrochloride and naloxone hydrochloride in the treatment of opioid use disorder.Design, setting, and participantsThis outpatient, double-blind, double-dummy randomized clinical trial was conducted at 35 sites in the United States from December 29, 2015, through October 19, 2016. Participants were treatment-seeking adults with moderate-to-severe opioid use disorder.InterventionsRandomization to daily SL placebo and weekly (first 12 weeks; phase 1) and monthly (last 12 weeks; phase 2) SC buprenorphine (SC-BPN group) or to daily SL buprenorphine with naloxone (24 weeks) with matched weekly and monthly SC placebo injections (SL-BPN/NX group).Main outcomes and measuresPrimary end points tested for noninferiority were response rate (10% margin) and the mean proportion of opioid-negative urine samples for 24 weeks (11% margin). Responder status was defined as having no evidence of illicit opioid use for at least 8 of 10 prespecified points during weeks 9 to 24, with 2 of these at week 12 and during month 6 (weeks 21-24). The mean proportion of samples with no evidence of illicit opioid use (weeks 4-24) evaluated by a cumulative distribution function (CDF) was an a priori secondary outcome with planned superiority testing if the response rate demonstrated noninferiority.ResultsA total of 428 participants (263 men [61.4%] and 165 women [38.6%]; mean [SD] age, 38.4 [11.0] years) were randomized to the SL-BPN/NX group (n = 215) or the SC-BPN group (n = 213). The response rates were 31 of 215 (14.4%) for the SL-BPN/NX group and 37 of 213 (17.4%) for the SC-BPN group, a 3.0% difference (95% CI, -4.0% to 9.9%; P < .001). The proportion of opioid-negative urine samples was 1099 of 3870 (28.4%) for the SL-BPN/NX group and 1347 of 3834 (35.1%) for the SC-BPN group, a 6.7% difference (95% CI, -0.1% to 13.6%; P < .001). The CDF for the SC-BPN group (26.7%) was statistically superior to the CDF for the SL-BPN/NX group (0; P = .004). Injection site adverse events (none severe) occurred in 48 participants (22.3%) in the SL-BPN/NX group and 40 (18.8%) in the SC-BPN group.Conclusions and relevanceCompared with SL buprenorphine, depot buprenorphine did not result in an inferior likelihood of being a responder or having urine test results negative for opioids and produced superior results on the CDF of no illicit opioid use. These data suggest that depot buprenorphine is efficacious and may have advantages.Trial registrationClinicalTrials.gov Identifier: NCT02651584.
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2018-12-01 | GSE121242 | GEO
Project description:BackgroundThere is evidence of heterogeneity within treatment-resistant schizophrenia (TRS), with some people not responding to antipsychotic treatment from illness onset and others becoming treatment-resistant after an initial response period. These groups may have different aetiologies.AimThis study investigates sociodemographic and clinical correlates of early onset of TRS.MethodEmploying a retrospective cohort design, we do a secondary analysis of data from a cohort of people with TRS attending the South London and Maudsley. Regression analyses were conducted to identify the correlates of the length of treatment to TRS. Predictors included the following: gender, age, ethnicity, problems with positive symptoms, problems with activities of daily living, psychiatric comorbidities, involuntary hospitalisation and treatment with long-acting injectable antipsychotics.ResultsIn a cohort of 164 people with TRS (60% were men), the median length of treatment to TRS was 3 years and 8 months. We observed no cut-off on the length of treatment until TRS presentation differentiating between early and late TRS (i.e. no bimodal distribution). Having mild to very severe problems with hallucinations and delusions at the treatment start was associated with earlier TRS (~19 months earlier). In sensitivity analyses, including only complete cases (subject to selection bias), treatment with a long-acting injectable antipsychotic was additionally associated with later TRS (~15 months later).ConclusionOur findings do not support a clear separation between early and late TRS but rather a continuum of the length of treatment before TRS onset. Having mild to very severe problems with positive symptoms at treatment start predicts earlier onset of TRS.
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