Factors associated with the absence of cocaine craving in treatment-seeking individuals during inpatient cocaine detoxification.

BACKGROUND: Anecdotal evidence suggests a substantial proportion of individuals with cocaine use disorder do not report craving during inpatient detoxification. OBJECTIVE: To examine prevalence and clinical correlates of consistent absence of cocaine craving among inpatients during detoxification. We hypothesized that craving absence would be associated with less severity of cocaine use, depression, and anxiety. Alternative explanations were also explored. METHODS: Craving absence (i.e., non-cravers) was defined as a daily score of zero across two separate craving visual analogue scales in each of the inpatient days. Participants scoring ≥1 on ≥1 day were considered cravers. Severity of cocaine use disorder as well as in-treatment depression and anxiety were assessed. Alternative contributors included presence of cocaine and other substances in urine at admission, in-treatment prescription of psychotropic medications, treatment motivation, executive function, interoception, and social desirability. RESULTS: Eighty-seven participants (78.2% males) met criteria as either non-cravers (n = 29; 33.3%) or cravers (n = 58; 66.7%). Mean length of admission in non-cravers and cravers was, respectively, 10.83 and 13.16 days. Binary logistic regression model showed that non-cravers scored significantly lower than cravers on cocaine use during last month before treatment (OR, 95% CI; 0.902, 0.839-0.970), in-treatment depression (OR, 95% CI; 0.794, 0.659-0.956), and in-treatment prescribing of antipsychotics (OR, 95% CI; 0.109, 0.014-0.823). Model prediction accuracy was 88.9%. CONCLUSIONS: One in three patients undergoing inpatient detoxification experienced absence of craving, linked to less pretreatment cocaine use, better mood, and decreased administration of antipsychotics. Findings may inform pretreatment strategies and improve treatment cost-effectiveness.

Cocaine addiction is associated with abnormal prefrontal function, increased striatal connectivity and sensitivity to monetary incentives, and decreased connectivity outside the human reward circuit.

Cocaine addiction has been associated with increased sensitivity of the human reward circuit to drug-related stimuli. However, the capacity of non-drug incentives to engage this network is poorly understood. Here, we characterized the functional sensitivity to monetary incentives and the structural integrity of the human reward circuit in abstinent cocaine-dependent (CD) patients and their matched controls. We assessed the BOLD response to monetary gains and losses in 30 CD patients and 30 healthy controls performing a lottery task in a magnetic resonance imaging scanner. We measured brain gray matter volume (GMV) using voxel-based morphometry and white matter microstructure using voxel-based fractional anisotropy (FA). Functional data showed that, after monetary incentives, CD patients exhibited higher activation in the ventral striatum than controls. Furthermore, we observed an inverted BOLD response pattern in the prefrontal cortex, with activity being highest after unexpected high gains and lowest after losses. Patients showed increased GMV in the caudate and the orbitofrontal cortex, increased white matter FA in the orbito-striatal pathway but decreased FA in antero-posterior association bundles. Abnormal activation in the prefrontal cortex correlated with GMV and FA increases in the orbitofrontal cortex. While functional abnormalities in the ventral striatum were inversely correlated with abstinence duration, structural alterations were not. In conclusion, results suggest abnormal incentive processing in CD patients with high salience for rewards and punishments in subcortical structures but diminished prefrontal control after adverse outcomes. They further suggest that hypertrophy and hyper-connectivity within the reward circuit, to the expense of connectivity outside this network, characterize cocaine addiction.

Satisfaction With Methadone Among Heroin-Dependent Patients With Current Substance Use Disorders During Methadone Maintenance Treatment.

Methadone maintenance treatment (MMT) has long been used to treat heroin-dependent patients. However, satisfaction with methadone in this patient population is unknown. The aim of this cross-sectional case-control study was to evaluate satisfaction with methadone in heroin-dependent patients with current substance use disorders (SUDs). Cases included 152 methadone-maintained patients with current SUD, requiring inpatient detoxification treatment, and controls included 33 methadone-maintained patients in sustained full remission for SUD. Satisfaction with methadone as a medication to treat heroin addiction was measured by using the Scale to Assess Satisfaction with Medications for Addiction Treatment-methadone for heroin addiction (SASMAT-METHER). The SASMAT-METHER subscales assess the following domains: personal functioning and well-being, antiaddictive effect on heroin, and antiaddictive effect on other substances. Compared with patients with remitted SUD, patients with current SUD scored lower on all SASMAT-METHER assessments. In such patients, overall SASMAT-METHER scores were independently and negatively associated with downward desired adjustment of methadone dose and days of heroin use during last month; although various sets of factors were independently associated with each of the SASMAT-METHER subscales, the only determinant of dissatisfaction on all subscales was the desire for downward adjustment of methadone dose. In summary, MMT patients with current SUD are less satisfied with methadone than MMT patients with remitted SUD. In patients with current SUD, downward desired adjustment of methadone dose and days of heroin use during last month are independently associated with overall dissatisfaction with methadone.

Pharmacological and clinical dilemmas of prescribing in co-morbid adult attention-deficit/hyperactivity disorder and addiction.

The present article reviews whether available efficacy and safety data support the pharmacological treatment of adult attention-deficit/hyperactivity disorder (ADHD) in patients with concurrent substance use disorders (SUD). Arguments for and against treating adult ADHD with active SUD are discussed. Findings from 19 large open studies and controlled clinical trials show that the use of atomoxetine or extended-release methylphenidate formulations, together with psychological therapy, yield promising though inconclusive results about short term efficacy of these drugs in the treatment of adult ADHD in patients with SUD and no other severe mental disorders. However, the efficacy of these drugs is scant or lacking for treating concurrent SUD. No serious safety issues have been associated with these drugs in patients with co-morbid SUD-ADHD, given their low risk of abuse and favourable side effect and drug-drug interaction profile. The decision to treat adult ADHD in the context of active SUD depends on various factors, some directly related to SUD-ADHD co-morbidity (e.g. degree of diagnostic uncertainty for ADHD) and other factors related to the clinical expertise of the medical staff and availability of adequate resources (e.g. the means to monitor compliance with pharmacological treatment). Our recommendation is that clinical decisions be individualized and based on a careful analysis of the advantages and disadvantages of pharmacological treatment for ADHD on a case-by-case basis in the context of active SUD.

Assessing predictors of adequate individual buprenorphine maintenance dosage for the treatment of opioid use disorder: Listening to the patient.

OBJECTIVE: Dose optimization plays a key role in determining clinical outcomes in patients on opioid agonist treatment (OAT). The objective of this study was to identify the variables independently associated with buprenorphine/naloxone (B/N) dose adequacy in patients with opiate use disorder (OUD). METHOD: Cross-sectional study of a convenience sample of patients with OUD treated with B/N (n = 315) in four regions in Spain. The Opiate Dosage Adequacy Scale (ODAS) was used to determine B/N dose adequacy. The ODAS evaluate the six components of the "dose adequacy" construct, as follows: continued use of heroin; narcotic blockade or crossed tolerance; objective opioid withdrawal symptoms (OWS); subjective OWS; craving for heroin; and overmedication. A binomial logistic regression analysis was performed to identify the variables associated with the condition "ODAS Adequate B/N dose". Participants completed a battery of instruments to assess sociodemographic, substance use, clinical, and treatment variables. RESULTS: The B/N dose was considered adequate in 231 of the 315 participants (73.3 %). Two variables, satisfaction with B/N as a medication (OR=5.764, 95 % CI=2.211-15.030) and patient-perceived participation in B/N dose decisions (OR=1.790, 95 % CI=1221-2623), were independently, significantly, and positively associated with the "ODAS Adequate B/N dose" condition. While the severity of heroin dependence was significantly associated with buprenorphine dose adequacy in the bivariate analyses, significance was lost in the full regression model. CONCLUSION: Satisfaction with B/N as a medication and patient-perceived involvement in the dose decision are associated with clinician-assessed dose adequacy. In the context of good clinical practice, it is important to take into account both of these variables to individualize the prescribed dose through a shared decision-making process.

Satisfaction with methadone as a medication: psychometric properties of the Spanish version of the treatment satisfaction questionnaire for medication.

There is a manifest lack of psychometrically sound instruments designed for specific and multidimensional assessment of satisfaction with methadone as a medication within the context of methadone maintenance treatment. Therefore, it may be worthwhile to assess the pertinence and utility of using a generic and multidimensional medication satisfaction instrument that has not been specifically developed for use in methadone maintenance treatment.The aim of this study was thus to explore the psychometric properties of the Spanish version of the Treatment Satisfaction Questionnaire for Medication (TSQM version 1.4 [Health Qual Life Outcomes. 2004;2:12]) in a sample of methadone-maintained heroin-dependent patients.Two hundred three methadone-maintained patients filled out the TSQM and other several measures related to the construct of patient satisfaction (eg, Verona Service Satisfaction Scale for methadone treatment). Dimensionality of the TSQM was assessed by means of a confirmatory factor analysis. Internal consistency was examined using the ordinal coefficient α. Spearman correlations were used to explore the relationship between the TSQM and the measures conceptually related to patient satisfaction.Regarding the dimensionality of the TSQM, its original factor structure adequately fitted the data (Satorra-Bentler χ58, 72.14 [P = 0.100]; root-mean-square error of approximation, 0.045; comparative fit index, 0.978). All but 1 of the 4 TSQM subscales showed acceptable to good internal consistency values (0.78-0.89). The dimensions of the TSQM were differentially and congruently correlated with related measures.The results strongly suggest the TSQM value as a brief, generic, and psychometrically sound instrument to assess satisfaction with methadone as a medication in a multidimensional manner. Notwithstanding, more research is needed not only to assess the generalizability of these findings but also to provide pieces of evidence for other psychometric properties, especially the TSQM predictive validity.

Feasibility of double-blind clinical trials with oral diacetylmorphine: a randomized controlled phase II study in an inpatient setting.

The aim of this study was to evaluate the feasibility of conducting double-blind controlled randomized clinical trials using twice-a-day immediate-release oral diacetylmorphine (DAM) in heroin-dependent patients, by means of measuring the capacity of oral DAM to block opiate withdrawal and clinicians' ability to distinguish it from morphine and methadone. This was a randomized, phase II, double-blind, multicenter pilot study comparing immediate-release oral DAM, slow-release oral morphine and oral methadone administered twice a day during 10 days. Forty-five heroin-dependent patients were randomly assigned to these three treatment groups in an inpatient regime. Patients were stabilized with a mean of 350 mg (SD = 193) of immediate-release oral DAM, 108 mg (SD = 46.2) of slow-release oral morphine and 40 mg (SD = 17.9) of methadone. No statistically significant differences were found between any studied medication in clinical outcome. Neither patients nor clinicians were able to identify the administered medication. This study shows the feasibility of double-blind clinical trials using b.i.d. immediate-release oral DAM allowing further phase III clinical trials in the process of introducing oral DAM as a medication for heroin-dependent patients not responding to standard maintenance treatments.

Features and prevalence of patients with probable adult attention deficit hyperactivity disorder who request treatment for cocaine use disorders.

To characterize those patients with probable adult attention deficit hyperactivity disorder (ADHD) who ask for treatment of cocaine use disorders; to estimate the prevalence of probable adult ADHD among these patients. This is a cross-sectional and multi-center study performed at outpatient resources of 12 addiction treatment centers in Spain. Participants were treatment-seeking primary cocaine abusers recruited consecutively at one center and through convenience sampling at the other centers. Assessments included semi-structured clinical interview focused on Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV) ADHD criteria adapted to adulthood, and the Wender-Utah Rating Scale (WURS) for screening childhood history of ADHD according to patients. Probable adult ADHD was diagnosed when patients met DSM-IV criteria of ADHD in adulthood and scored WURS>32. All participants were diagnosed with current cocaine dependence (n=190) or abuse (n=15). Patients with probable adult ADHD, compared with patients having no lifetime ADHD, were more frequently male, reported higher impulsivity, and began to use nicotine, alcohol, cannabis, or cocaine earlier. Before starting the current treatment, patients with probable adult ADHD also showed higher cocaine craving for the previous day, less frequent cocaine abstinence throughout the previous week, and higher use of cocaine and tobacco during the previous month. Impulsivity and male gender were the only independent risk factors of probable adult ADHD in a logistic regression analysis. The prevalence of probable adult ADHD was 20.5% in the sub-sample of patients consecutively recruited (n=78). A diagnosis of probable adult ADHD strongly distinguishes among treatment-seeking cocaine primary abusers regarding past and current key aspects of their addictive disorder; one-fifth of these patients present with probable adult ADHD.

Patient and clinician's ratings of improvement in methadone-maintained patients: Differing perspectives?

BACKGROUND: In the last few years there seems to be an emerging interest for including the patients' perspective in assessing methadone maintenance treatment (MMT), with treatment satisfaction surveys being the most commonly-used method of incorporating this point of view. The present study considers the perspective of patients on MMT when assessing the outcomes of this treatment, acknowledging the validity of this approach as an indicator. The primary aim of this study is to evaluate the concordance between improvement assessment performed by two members of the clinical staff (a psychiatrist and a nurse) and assessment carried out by MMT patients themselves. METHOD: Patients (n = 110) and their respective psychiatrist (n = 5) and nurse (n = 1) completed a scale for assessing how the patient's condition had changed from the beginning of MMT, using the Patient Global Impression of Improvement scale (PGI-I) and the Clinical Global Impression of Improvement scale (CGI-I), respectively. RESULTS: The global improvement assessed by patients showed weak concordance with the assessments made by nurses (Quadratic-weighted kappa = 0.13, p > 0.05) and by psychiatrists (Quadratic-weighted kappa = 0.19, p = 0.0086), although in the latter, concordance was statistically significant. The percentage of improved patients was significantly higher in the case of the assessments made by patients, compared with those made by nurses (90.9% vs. 80%, Z-statistic = 2.10, p = 0.0354) and by psychiatrists (90.9% vs. 50%, Z-statistic = 6.48, p < 0.0001). CONCLUSIONS: MMT patients' perception of improvement shows low concordance with the clinical staff's perspective. Assessment of MMT effectiveness should also focus on patient's evaluation of the outcomes or changes achieved, thus including indicators based on the patient's experiences, provided that MMT aim is to be more patient centred and to cover different needs of patients themselves.

[HIV infection and injecting drug users: The urgency of reinvigorating harm-reduction programmes]. / Infección por VIH y usuarios de drogas por vía parenteral: Urgencia de la revitalización de los programas de reducción de daños.

The HIV epidemic among injecting drug users (IDUs) has led to greater support for the development of the harm-reduction perspective. This has proven to be a driving force for initially reluctant policy makers, managers and health care providers and has facilitated the implementation of harm-reduction programmes. This article presents recent data, both global and at the European and Spanish levels, about a) the epidemiological situation of HIV infection among IDUs, and b) the state of development of harm-reduction programmes. The incidence of HIV infection among IDUs not only continues to grow in different areas of, for example, Southeast Asia or Eastern Europe, but has even shown an upturn in cities or specific IDU groups in parts of Western Europe with apparently comprehensive harm-reduction strategies. On the other hand, of the 158 countries that acknowledge illegal drug use via injection in their territory, only 82 support harm reduction, explicitly in national policy documents and/or through the implementation or tolerance of interventions such as needle exchange programmes or opioid agonist programmes. These data, in conjunction with the high-quality and consistent evidence on the efficacy and effectiveness of harm- and risk-reduction programmes for HIV prevention and management among IDUs, should serve as a call to avoid complacency with regard to the diversification, accessibility and coverage of harm- and risk-reduction programmes for IDUs.

Towards a common metric for assessing heroin-dependent patient satisfaction with medications: Testing methadone and buprenorphine-naloxone.

BACKGROUND: Patient satisfaction with methadone or buprenorphine-naloxone can be multidimensionally and specifically assessed by using, respectively, the Scale to Assess Satisfaction with Medications for Addiction Treatment-Methadone for Heroin addiction (SASMAT-METHER) or the SASMAT-Buprenorphine-Naloxone for Heroin addiction (SASMAT-BUNHER). The factor structures of the SASMAT-METHER and SASMAT-BUNHER show substantial commonalities. The objective of the present study is to evaluate the replicability of the SASMAT-METHER factor structure using data from the SASMAT-BUNHER development study in order to obtain an instrument that can be used to compare patient satisfaction with methadone vs. buprenorphine-naloxone. METHOD: Secondary analysis of SASMAT-BUNHER data provided by 205 participants in the original validation study of that scale (Pérez de los Cobos et al., 2018). Using the SASMAT-METHER component solution (17 items, 3 factors) as the target structure, a principal component analysis was performed on the data set comprised of the corresponding 17 SASMAT-BUNHER items using an oblique semi-specified Procrustean rotation. Additionally, Tucker congruence coefficients were computed to examine the correspondence between the two solutions. RESULT: The factor structures of SASMAT-METHER and the 17-item version of the SASMAT-BUNHER can be considered equal given that the overall Tucker's congruence coefficient of factorial similarity was 0.972, with individual component congruencies ranging from 0.960 to 0.995. CONCLUSIONS: The SASMAT-METHER component solution can serve as a single common tool to compare methadone vs. buprenorphine-naloxone in terms of patient satisfaction. This finding supports the feasibility of using a common metric to specifically assess satisfaction with medications to treat heroin dependence.

A typology of heroin-dependent patients based on their history of self-injurious behaviours.

Self-injurious behaviours (SIB) can provide useful criteria for subtyping heroin-dependent patients, since SIB have been related to an opioid system dysfunction and they hinder patient management. The frequency of nine varieties of moderate/superficial SIB during active heroin use was assessed retrospectively in 164 heroin-dependent patients. A principal component analysis of SIB episodes revealed a four-component solution which accounted for 69.3% of the variance. The components were named as follows (percentage of variance explained by each component is enclosed in parentheses): 'SIB with objects' (27.3%), 'SIB by biting/scratching/hair-pulling' (18.2%), 'SIB by hitting' (12.3%), and 'SIB by picking scabs' (11.5%). A cluster analysis using the results of the principal component analysis enabled us to define three types of heroin-dependent patients, labelled: 'low-occurrence SIB cluster' (59.8%), 'high-occurrence scab-picking cluster' (31.7%) and 'high-occurrence hitting and cutting cluster' (8.5%). SIB by hitting was the most discriminatory component among clusters: its frequency was at a minimum in the low-occurrence SIB cluster, and attained a maximum in the high-occurrence hitting and cutting cluster. However, there were no differences among clusters regarding heroin-use variables. Patients from the low-occurrence SIB cluster, compared with those from the other two clusters, reported fewer episodes of SIB or suicide attempts and were diagnosed less frequently with bulimia. Patients from the high-occurrence scab-picking cluster had a very frequent history of these SIB, while the opposite was true in patients from the high-occurrence hitting and cutting cluster. Patients from this cluster probably presented staff members with the main management problems.

Quality of life and well-being from the perspective of patients on opioid agonist maintenance treatment: study protocol for a systematic review of qualitative research and a scoping review of measures.

BACKGROUND: Opioid agonist maintenance treatment (OAMT) is a first-line treatment for heroin dependence, but its effectiveness has been assessed primarily through clinical outcomes with a limited attention to patient perspectives. Despite the increased use of patient reported outcome measures their patient-centeredness is highly questionable. This is the protocol of a systematic review of qualitative research on how OAMT users construct the meaning of their quality of life and well-being and a scoping review of instruments that measure these domains. METHODS: We will conduct a systematic review of qualitative research exploring the views of quality of life of patients on OAMT (registration number CRD42018086490). According pre-specified eligibility criteria, we will include studies from a comprehensive search of bibliographical databases from their inception. We will extract data from included studies and assess their risk of bias with the CASP appraisal criteria, and will implement a thematic analysis to generate a set of interpretative analytical themes ascertaining their confidence using the CERQual approach. We will implement similar methods to conduct a scoping review to assess to what extent the existing measures of these domains were focused on user's views, assessing their validity using the COSMIN methodology, and summarizing their characteristics and level of patient centeredness. CONCLUSION: The findings from the reviews will contribute to obtain a genuine understanding of the perspective from users on OAMT regarding their perception of well-being and quality of life and will likely lead to greater patient centeredness when assessing such variables, which in turn may contribute to a more patient-centered care.

DSM-IV criteria-based clinical subtypes of cannabis use disorders: results from the National Epidemiological Survey on Alcohol and Related Conditions (NESARC).

Prior research documented high homogeneity of alcohol use disorders (AUDs) as clinical entities. However, it is unknown whether this finding extends to other substance use disorders. We investigated this by examining the prevalence of all possible DSM-IV criteria-based clinical subtypes of current and lifetime cannabis use disorders in the general population. The number of possible (i.e., theoretical) clinical subtypes of cannabis abuse and dependence based on different combinations of the DSM-IV criteria was calculated using the combinatorial function. This number was compared with the subtypes actually observed in the National Epidemiologic Survey on Alcohol and Related Conditions (NESARC), a large U.S. national sample (N=43,093). Clinical and demographic correlates of the subtypes were examined with chi2 tests whose target population was the United States civilian non-institutionalized population. All DSM-IV cannabis abuse and dependence criteria were assessed with the Alcohol Use Disorder and Associated Disabilities Interview Schedule-DSM-IV Version (AUDADIS-IV). Of all possible cannabis dependence subtypes, 29 (69%) were observed in the 12-month timeframe, and 41 (98%) in the lifetime timeframe. The corresponding numbers of subtypes for cannabis abuse were 12 (75%), current and 15 (100%), lifetime. These findings suggest that, in contrast to alcohol disorders, cannabis use disorders were highly heterogeneous. Future research should investigate whether there are differences in the course and treatment response of these clinical subtypes of cannabis use disorders, and the heterogeneity of other substance use disorders.

Heroin-dependent patient satisfaction with methadone as a medication influences satisfaction with basic interventions delivered by staff to implement methadone maintenance treatment.

PURPOSE: The aim of the present study was to test a structural equation model of patient satisfaction with different key facets of methadone maintenance treatment (MMT). In this model, the three dimensions of patient satisfaction with methadone as a medication (ie, personal functioning and well-being, anti-addictive effect on heroin, and anti-addictive effect on non-opioid substances) were expected to predict satisfaction with the basic interventions delivered by the staff of treatment centers to implement MMT. PATIENTS AND METHODS: A sample of 210 heroin-dependent patients, resistant to MMT treatment (mean age =41.66 years, SD =6.50; 75.7% male), participated voluntarily in this study. Preliminary analysis based on exploratory structural equation modeling supported the expected three-factor measurement model of the scale to assess satisfaction with medications for addiction treatment - methadone for heroin addiction. Moreover, the 15 items measuring staff's basic interventions were shown to be compatible with the expected single-factor measurement model. Then, both measurement models were included in a structural model. RESULTS: Results of this model show that patient satisfaction with the compatibility of methadone with personal functioning and well-being, as well as with the anti-addictive effects of methadone on non-opioid substances, predicts satisfaction with basic interventions conducted at methadone treatment centers (ß=0.191 and ß=0.152, respectively). CONCLUSION: Our results provide further understanding regarding patient satisfaction with MMT, which could help professionals to better understand patient perspective and experience during MMT.

Evidence of validity and reliability of the Opiate Dosage Adequacy Scale (ODAS) in a sample of heroin addicted patients in buprenorphine/naloxone maintenance treatment.

OBJECTIVE: The Opiate Dosage Adequacy Scale (ODAS) is a clinical tool to individually measure the "adequacy" of opioid doses in patients on maintenance treatment. The aim of this paper is to provide evidence for the validity and reliability of the ODAS in a sample of patients in buprenorphine/naloxone (B/N) maintenance treatment. METHOD: Cross-sectional study of a convenience sample of B/N-treated patients (n = 316) from four Autonomous Communities in Spain. Participants completed a battery of instruments to assess the following: buprenorphine dose adequacy; heroin dependence severity; psychological adjustment; and patient-desired adjustment of buprenorphine dose. RESULTS: Exploratory Factor Analysis identified four factors from the ODAS that together account for 85.4% of the total variance: "Heroin craving and use"; "Overmedication"; "Objective opiate withdrawal symptoms (OWS)" and 'Subjective OWS'. Compared to patients with an "inadequate" B/N dose (ODAS), patients with "adequate" doses had less heroin use in the last week (0.01 vs. 0.40; t = -2.73; p < 0.01, 95% CI: -0.67, -0.10), less severe heroin dependence (2.20 vs. 5.26, t = -5.14, p < 0.001; 95% CI: -4.23, -1.88), less psychological distress (3.00 vs. 6.31, t = -4.37, p < 0.001; 95% CI: -4.80, -1.81), and greater satisfaction with their doses (42.1% vs. 13.6%, χ2 = 14.44, p < 0.01). Cronbach's alpha coefficient was 0.76 (0.81, 0.92, 0.94, and 0.93, respectively, for the four factor dimensions). CONCLUSION: These findings support the validity and reliability of the ODAS as a tool to measure and assess buprenorphine dose adequacy in the context of an opioid dependency treatment program.

A cluster-analytic profiling of heroin-dependent patients based on level, clinical adequacy, and patient-desired adjustment of buprenorphine dosage during buprenorphine-naloxone maintenance treatment in sixteen Spanish centers.

BACKGROUND: Buprenorphine dosage is a crucial factor influencing outcomes of buprenorphine treatment for heroin use disorders. Therefore, the aim of the present study is to identify naturally occurring profiles of heroin-dependent patients regarding individualized management of buprenorphine dosage in clinical practice of buprenorphine-naloxone maintenance treatment. METHODS: 316 patients receiving buprenorphine-naloxone maintenance treatment were surveyed at 16 Spanish centers during the stabilization phase of this treatment. Patients were grouped using cluster analysis based on three key indicators of buprenorphine dosage management: dose, adequacy according to physician, and adjustment according to patient. The clusters obtained were compared regarding different facets of patient clinical condition. RESULTS: Four clusters were identified and labeled as follows (buprenorphine average dose and percentage of participants in each cluster are given in brackets): "Clinically Adequate and Adjusted to Patient Desired Low Dosage" (2.60 mg/d, 37.05%); "Clinically Adequate and Adjusted to Patient Desired High Dosage" (10.71 mg/d, 29.18%); "Clinically Adequate and Patient Desired Reduction of Low Dosage" (3.38 mg/d, 20.0%); and "Clinically Inadequate and Adjusted to Patient Desired Moderate Dosage" (7.55 mg/d, 13.77%). Compared to patients from the other three clusters, participants in the latter cluster reported more frequent use of heroin and cocaine during last week, lower satisfaction with buprenorphine-naloxone as a medication, higher prevalence of buprenorphine-naloxone adverse effects and poorer psychological adjustment. CONCLUSIONS: Our results show notable differences between clusters of heroin-dependent patients regarding buprenorphine dosage management. We also identified a group of patients receiving clinically inadequate buprenorphine dosage, which was related to poorer clinical condition.

Development and validation of the scale to assess satisfaction with medications for addiction treatment - Buprenorphine-naloxone for heroin addiction (SASMAT-BUNHER).

BACKGROUND: Until now, no specific tool has been available to measure heroin-dependent patient satisfaction with buprenorphine-naloxone as a medication. The purpose of the present study was to develop the Scale to Assess Satisfaction with Medications for Addiction Treatment-Buprenorphine-Naloxone for Heroin addiction (SASMAT-BUNHER) and to examine its validity and reliability. METHODS: The SASMAT-BUNHER was developed from a pool of 44 self-administered items grouped into nine theoretical domains, as follows: Overall Satisfaction, Pharmacotherapy, Initiation, Anti-Addictive Effect on Heroin, Mental State, Physical State, Personal Functioning, Acceptability, and Anti-Addictive Effect on Secondary Substances. The Treatment Satisfaction Questionnaire for Medication 1.4 version (TSQM 1.4) was used for convergent validation. Participants were 316 heroin-dependent patients in maintenance treatment with buprenorphine-naloxone sublingual tablets at 16 different treatment centres. RESULTS: Principal component analysis of the SASMAT-BUNHER revealed a 5-factor structure that accounted for 65.1% of total variance. Based on similarities between empirically-obtained factors and theoretical domains, Factors 1 through 5 were named 'Mental and Physical State' (10 items), 'Anti-Addictive Effect on Other Substances' (5 items), 'Anti-Addictive Effect on Heroin' (4 items), 'Personal Functioning' (3 items), and 'Acceptability' (4 items). All factors showed acceptable internal consistency (Cronbach's alpha coefficients: 0.744-0.925) and test-retest reliability (intraclass correlation coefficients: 0.704-0.895). Correlation between SASMAT-BUNHER and TSQM 1.4 total scores was moderate (Pearson r = 0.552). Moreover, SASMAT-BUNHER total scores of patients reporting absence of buprenorphine-naloxone side effects were higher than those of their counterparts. CONCLUSION: These results support the validity and reliability of the SASMAT-BUNHER.

Allelic and genotypic associations of DRD2 TaqI A polymorphism with heroin dependence in Spanish subjects: a case control study.

BACKGROUND: Conflicting associations with heroin dependence have been found involving the A1 allele of dopamine D2 receptor gene (DRD2) TaqI A polymorphism. METHODS: We compared two samples of unrelated Spanish individuals, all of European origin: 281 methadone-maintained heroin-dependent patients (207 males and 74 females) who frequently used non-opioid substances, and 145 control subjects (98 males and 47 females). RESULTS: The A1-A1 genotype was detected in 7.1% of patients and 1.4% of controls (P = 0.011, odds ratio = 5.48, 95% CI 1.26-23.78). Although the A1 allele was not associated with heroin dependence in the entire sample, the frequency of A1 allele was higher in male patients than in male controls (24.4% vs. 16.3%, P = 0.024, odds ratio = 1.65, 95% CI 1.07-2.57). A logistic regression analysis showed an interaction between DRD2 alleles and gender (odds ratio = 1.77, 95% CI 1.15-2.70). CONCLUSION: Our results indicate that, in Spanish individuals, genotypes of the DRD2 TaqI A polymorphism contribute to variations in the risk of heroin dependence, while single alleles contribute only in males.