Association of chronic non-cancer pain status and buprenorphine treatment retention among individuals with opioid use disorder: Results from electronic health record data.

Background: Although chronic non-cancer pain (CNCP) is common among individuals with opioid use disorder (OUD), its impact on buprenorphine treatment retention is unclear. The goal of this study was to use electronic health record (EHR) data to examine the association of CNCP status and 6-month buprenorphine retention among patients with OUD. Methods: We analyzed EHR data of patients with OUD who received buprenorphine treatment in an academic healthcare system between 2010 and 2020 (N = 676). We used Kaplan-Meier curves and Cox proportional hazards regression to estimate risk of buprenorphine treatment discontinuation (≥90 days between subsequent prescriptions). We used Poisson regression to estimate the association of CNCP and the number of buprenorphine prescriptions over 6 months. Results: Compared to those without CNCP, a higher proportion of patients with CNCP were of older age and had comorbid diagnoses for psychiatric and substance use disorders. There were no differences in the probability of buprenorphine treatment continuation over 6 months by CNCP status (p = 0.15). In the adjusted cox regression model, the presence of CNCP was not associated with time to buprenorphine treatment discontinuation (HR = 0.90, p = 0.28). CNCP status was associated with a higher number of prescriptions over 6 months (IRR = 1.20, p < 0.01). Conclusions: These findings suggest that the presence of CNCP alone cannot be reliably associated with buprenorphine retention in patients with OUD. Nonetheless, providers should be aware of the association between CNCP and greater psychiatric comorbidity among patients with OUD when developing treatment plans. Research on the influence of additional characteristics of CNCP on treatment retention is needed.

A Randomized Controlled Trial of an Integrated Alcohol Reduction Intervention in Patients With Hepatitis C Infection.

BACKGROUND AND AIMS: Hepatitis C virus (HCV) and alcohol use are patient risk factors for accelerated fibrosis progression, yet few randomized controlled trials have tested clinic-based alcohol interventions. APPROACH AND RESULTS: A total of 181 patients with HCV and qualifying alcohol screener scores at three liver center settings were randomly assigned to the following: (1) medical provider-delivered Screening, Brief Intervention, and Referral to Treatment (SBIRT), including motivational interviewing counseling and referral out for alcohol treatment (SBIRT-only), or (2) SBIRT plus 6 months of integrated colocated alcohol therapy (SBIRT + Alcohol Treatment). The timeline followback method was used to assess alcohol use at baseline and 3, 6, and 12 months. Coprimary outcomes were alcohol abstinence at 6 months and heavy drinking days between 6 and 12 months. Secondary outcomes included grams of alcohol consumed per week at 6 months. Mean therapy hours across 6 months were 8.8 for SBIRT-only and 10.1 for SBIRT + Alcohol Treatment participants. The proportion of participants exhibiting full alcohol abstinence increased from baseline to 3, 6, and 12 months in both treatment arms, but no significant differences were found between arms (baseline to 6 months, 7.1% to 20.5% for SBIRT-only; 4.2% to 23.3% for SBIRT + Alcohol Treatment; P = 0.70). Proportions of participants with any heavy drinking days decreased in both groups at 6 months but did not significantly differ between the SBIRT-only (87.5% to 26.7%) and SBIRT + Alcohol Treatment (85.7% to 42.1%) arms (P = 0.30). Although both arms reduced average grams of alcohol consumed per week from baseline to 6 and 12 months, between-treatment effects were not significant. CONCLUSIONS: Patients with current or prior HCV infection will engage in alcohol treatment when encouraged by liver medical providers. Liver clinics should consider implementing provider-delivered SBIRT and tailored alcohol treatment referrals as part of the standard of care.

Pilot Randomized Controlled Trial of a Novel Smoking Cessation App Designed for Individuals With Co-Occurring Tobacco Use Disorder and Serious Mental Illness.

INTRODUCTION: High rates of tobacco use among people with serious mental illness (SMI), along with their unique needs, suggest the importance of developing tailored smoking cessation interventions for this group. Previous early-phase work empirically validated the design and content of Learn to Quit, a theory-based app designed for this population. METHODS: In a pilot randomized controlled trial, we compared the feasibility, acceptability, and preliminary efficacy of Learn to Quit versus QuitGuide, an app designed for the general population. All participants received nicotine replacement therapy and technical assistance. Daily smokers with SMI (N = 62) participated in the trial with outcomes assessed at weeks 4, 8, 12, and 16. RESULTS: Compared to QuitGuide, Learn to Quit participants had similar number of days of app use (34 vs. 32, p = .754), but larger number of app interactions (335 vs. 205; p = .001), longer durations of app use (4.24 hrs. vs. 2.14 hrs; p = .044), and higher usability scores (85 vs. 79, p = .046). At week 16, Learn to Quit led to greater reductions in cigarettes per day (12.3 vs. 5.9 for QuitGuide; p = 0.10). Thirty-day point prevalence abstinence was verified in 12% of Learn to Quit participants versus 3% of QuitGuide participants (odds ratio = 3.86, confidence interval = 0.41 to 36, p = .239). Changes in psychiatric symptoms and adverse events were not clinically significant between conditions. CONCLUSIONS: This pilot trial provides strong evidence of Learn to Quit's usability, feasibility, and safety. Preliminary evidence suggests the app may be efficacious. A randomized controlled efficacy trial is needed to test the app in a larger sample of smokers with SMI. IMPLICATIONS: This study suggests that the Learn to Quit app is a feasible approach to deliver smoking cessation treatment in patients with co-occurring tobacco use disorder and SMI. This means that, if found efficacious, this technology could be used to deploy smoking cessation treatment to larger segments of this population, hence improving public health. Therefore, a randomized controlled trial should be conducted to examine the efficacy of this digital intervention.

Prevalence and patterns of opioid misuse and opioid use disorder among primary care patients who use tobacco.

BACKGROUND: Current data suggest that opioid misuse or opioid use disorder (OUD) may be over represented among tobacco users. However, this association remains understudied in primary care settings. A better understanding of the extent of heterogeneity in opioid misuse among primary care patients who use tobacco may have implications for improved primary care-based screening, prevention, and intervention approaches. METHODS: Data were derived from a sample of 2000 adult (aged ≥18) primary care patients across 5 distinct clinics. Among past-year tobacco users (n = 882), we assessed the prevalence of opioid misuse and OUD by sociodemographic characteristics and past-year polysubstance use. Latent class analysis (LCA) was used to identify heterogeneous subgroups of tobacco users according to past-year polysubstance use patterns. Multinomial logistic regression was used to examine variables associated with LCA-defined class membership. RESULTS: Past-year tobacco use was reported by >84% of participants who reported past-year opioid misuse or OUD. Among those reporting past-year tobacco use, the prevalence of past-year opioid misuse and OUD was 14.0% and 9.5%, respectively. The prevalence of opioid misuse or OUD was highest among tobacco users who were male or unemployed. Three LCA-defined classes among tobacco users were identified including a tobacco-minimal drug use group (78.0%), a tobacco-cannabis use group (10.1%), and a tobacco-opioid/polydrug use group (11.9%). Class membership differed by sociodemographic characteristics. CONCLUSIONS: Results from this study support the benefit of more comprehensive assessment of and/or monitoring for opioid misuse among primary care patients who use tobacco, particularly for those who are male, unemployed, or polydrug users.

The Hepatitis C-Alcohol Reduction Treatment (Hep ART) intervention: Study protocol of a multi-center randomized controlled trial.

INTRODUCTION: Among patients with hepatitis C virus (HCV) infection, alcohol synergistically increases the risk of cirrhosis, hepatocellular carcinoma, and death. Randomized controlled trials of integrated models of HCV-alcohol treatment have been recommended but only performed in patients with severe alcohol use disorders. OBJECTIVES: This pragmatic randomized controlled trial seeks to compare clinical effectiveness and cost-effectiveness of integrated alcohol treatment compared to enhanced treatment as usual (TAU) on alcohol consumption and economic outcomes among patients ever infected with HCV. METHODS: Patients recruited from three liver centers who had current or prior chronic HCV and qualifying alcohol screener scores were randomly assigned to enhanced TAU or the Hepatitis C-Alcohol Reduction Treatment (Hep ART) intervention. All patients received enhanced TAU, consisting of a patient-administered alcohol screener and care from medical providers who were trained in Screening, Brief Intervention and Referral to Treatment (SBIRT), including brief motivational interviewing counseling. The Hep ART intervention combined enhanced TAU with up to six months of integrated co-located individual and/or group therapy that provided motivational, cognitive, and behavioral strategies to reduce alcohol consumption. The Timeline Followback (TLFB) Method was used to evaluate alcohol use at baseline, 3, 6, and 12 months. Primary outcomes are alcohol abstinence and fewer heavy drinking days, and for the cost-effectiveness analysis, measures included grams of alcohol consumed. DISCUSSION: This study will determine whether Hep ART, a six-month integrated alcohol treatment, compared to enhanced TAU, is both clinically effective and cost-effective in patients with a history of comorbid HCV and alcohol use.

Prevalence, patterns, and correlates of multiple substance use disorders among adult primary care patients.

BACKGROUND: Addressing multiple substance use disorders (SUDs) in primary care-based screening and intervention may improve SUD treatment access, engagement, and outcomes. To inform such efforts, research is needed on the prevalence and patterns of multiple SUDs among primary care patients. METHODS: Data were analyzed from a sample of 2000 adult (aged ≥ 18) primary care patients recruited for a multisite National Drug Abuse Treatment Clinical Trials Network (CTN) study (CTN-0059). Past-year DSM-5 SUDs (tobacco, alcohol, and drug) were assessed by the modified Composite International Diagnostic Interview. Prevalence and correlates of multiple versus single SUDs were examined. Latent class analysis (LCA) was used to explore patterns of multiple SUDs. RESULTS: Multiple SUDs were found among the majority of participants with SUD for alcohol, cannabis, prescription opioids, cocaine, and heroin. Participants who were male, ages 26-34, less educated, and unemployed had increased odds of multiple SUDs compared to one SUD. Having multiple SUDs was associated with greater severity of tobacco or alcohol use disorder. LCA of the sample identified three classes: class 1 (83.7%) exhibited low prevalence of all SUDs; class 2 (12.0%) had high-moderate prevalence of SUDs for tobacco, alcohol, and cannabis; class 3 (4.3%) showed high prevalence of SUD for tobacco, opioids, and cocaine. LCA-defined classes were distinguished by sex, age, race, education, and employment status. CONCLUSIONS: Findings suggest that primary care physicians should be aware of multiple SUDs when planning treatment, especially among adults who are male, younger, less educated, or unemployed. Interventions that target multiple SUDs warrant future investigation.

Substance use disorders and medical comorbidities among high-need, high-risk patients with diabetes.

BACKGROUND: The majority of the U.S. healthcare resources are utilized by a small population characterized as high-risk, high-need persons with complex care needs (e.g., adults with multiple chronic conditions). Substance use disorders (SUDs) and mental health disorders (MHDs) are a driver of poor health and additional healthcare costs, but they are understudied among high-need patients. OBJECTIVE: We examine the prevalence and correlates of SUDs and MHDs among adults with high-risk diabetes, who are patients at the top 10% risk score for developing poor outcomes (hospital admission or death). METHODS: A risk algorithm developed from Duke University Health System electronic health records (EHRs) data was used to identify patients with high-risk diabetes for targeting home-based primary care. The EHR data of the 263 patients with high-risk diabetes were analyzed to understand patterns of SUDs and MHDs to inform care-coordinating efforts. RESULTS: Both SUDs (any SUD 48.3%, alcohol 12.5%, tobacco 38.8%, drug 23.2%) and MHDs (any MHD 74.9%, mood 53.2%, sleep 37.3%, anxiety 32.7%, schizophrenia/psychotics/delusional 14.8%, dementia/delirium/amnestic/cognitive 14.4%, adjustment 9.1%) were prevalent. Overall, 81.7% of the sample had SUD or MHD. Elevated odds of SUD were noted among men (tobacco, alcohol) and those who were never-married (alcohol, cannabis). African-American race (vs. other race/ethnicity) was associated with lower odds of anxiety disorders. CONCLUSION: While data are limited to one large academic health system, they provide clinical evidence revealing that 82% of patients with high-risk diabetes had SUD and/or MHD recorded in their EHRs, highlighting a need for developing service models to optimize high-risk care.

Prevalence and correlates of treatment utilization among adults with cannabis use disorder in the United States.

BACKGROUND: The increase in cannabis potency may have treatment implications for cannabis use disorder (CUD). Given the reported increase in prevalence of cannabis use among adults, there is a need to understand substance use treatment needs for CUD. METHODS: We examined demographics and behavioral health indicators of adults aged ≥18 years that met criteria for past-year CUD (n=10,943) in the 2005-2013 National Surveys on Drug Use and Health. We determined prevalence and correlates of past-year treatment use for alcohol/drug, any drug, and cannabis use related problems, to inform treatment efforts for CUD. RESULTS: The majority of adults with past-year CUD were young adults aged 18-25 or men, had low income, and did not attend college. Two-thirds of adults with CUD met criteria for cannabis dependence, which was comparatively common among younger adults, women, low-income or publicly insured adults, and college-educated adults. Nicotine dependence (40.92%) and alcohol (44.07%) or other drug use disorder (19.70%) were prevalent among adults with CUD. Overall, less than 13% of adults with CUD had received alcohol/drug use treatment the past year; only 7.8% received cannabis-specific treatment. There was no significant yearly variation in treatment use prevalence over 9 years. In particular, Asian-Americans, women, and college-educated adults underutilized cannabis-specific treatment. CONCLUSIONS: This large sample of adults with CUD reveals pervasive underutilization of cannabis-related treatment, especially in women, married adults, and those with college education, despite a high proportion of comorbid behavioral health problems.

Smoking and opioid detoxification: behavioral changes and response to treatment.

INTRODUCTION: The relevance of tobacco use in opioid addiction (OA) has generated a demand for available and more effective interventions. Thus, further analysis of less explored nicotine-opioid clinical interactions is warranted. METHODS: A post-hoc analysis of OA participants in a double-blind, randomized very low dose naltrexone (VLNTX) inpatient detoxification trial evaluated measures of opioid withdrawal and tobacco use. Intreatment smokers were compared with nonsmokers, or smokers who were not allowed to smoke. RESULTS: A total of 141 (81%) of 174 OA participants were smokers, all nicotine-dependent. Inpatient smoking was a predictor of opioid withdrawal discomfort. Intreatment smokers (n = 96) showed significantly higher opioid craving (F = 3.7, p < .001) and lower detoxification completion rate (χ(2) = 7.9, p < .02) compared with smokers who were not allowed to smoke (n = 45) or nonsmokers (n = 33). Smoking during treatment was associated with more elevated cigarette craving during detoxification (F = 4.1, p < .001) and a higher number of cigarettes smoked at follow-up (F = 3.6, p < .02). Among intreatment smokers, VLNTX addition to methadone taper was effective in easing opioid withdrawal and craving more than other treatments, whereas the combination VLNTX-clonidine was associated with significantly reduced cigarette craving and smoking during detoxification. CONCLUSIONS: Failure to address tobacco use may negatively affect pharmacologically managed opioid discontinuation. Opioid detoxification may offer a window of opportunity to expand smoking cessation treatment, hence improving OA outcomes. The observed effects support testing of VLNTX-clonidine in smoking cessation trials among individuals with or without substance abuse.

Evaluating brief screeners to discriminate between drug use disorders in a sample of treatment-seeking adults.

OBJECTIVE: The objective was to identify a potential core set of brief screeners for the detection of individuals with a substance use disorder (SUD) in medical settings. METHOD: Data were from two multisite studies that evaluated stimulant use outcomes of an abstinence-based contingency management intervention as an addition to usual care (National Drug Abuse Treatment Clinical Trials Network trials 006-007). The sample comprised 847 substance-using adults who were recruited from 12 outpatient substance abuse treatment settings across the United States. Alcohol and drug use disorders were assessed by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Checklist. Data were analyzed by factor analysis, item response theory (IRT), sensitivity and specificity procedures. RESULTS: Comparatively prevalent symptoms of dependence, especially inability to cut down for all substances, showed high sensitivity for detecting an SUD (low rate of false negative). IRT-defined severe (infrequent) and low discriminative items, especially withdrawal for alcohol, cannabis and cocaine, had low sensitivity in identifying cases of an SUD. IRT-defined less severe (frequent) and high discriminative items, including inability to cut down or taking larger amounts than intended for all substances and withdrawal for amphetamines and opioids, showed good-to-high values of area under the receiver operating characteristic curve in classifying cases and noncases of an SUD. CONCLUSION: Findings suggest the feasibility of identifying psychometrically reliable substance dependence symptoms to develop a two-item screen for alcohol and drug disorders.

History of depressive and/or anxiety disorders as a predictor of treatment response: a post hoc analysis of a 12-week, randomized, double-blind, placebo-controlled trial of paroxetine controlled release in patients with fibromyalgia.

BACKGROUND: Despite of a high comorbidity of depressive and/or anxiety disorders with fibromyalgia, information on the clinical implications of this comorbidity is limited but antidepressants are commonly prescribed to treat fibromyalgia in clinical practice. We investigated whether a history of depressive and/or anxiety disorders was associated with response to paroxetine controlled release (CR) in the treatment of fibromyalgia. METHODS: One hundred sixteen (116) fibromyalgia subjects were randomized to receive paroxetine CR or placebo for 12 weeks. The primary outcome was treatment response defined as >or=25% reduction in the Fibromyalgia Impact Questionnaire (FIQ) score. In multivariate logistic regression, we determined if a history of depression and/or anxiety disorders was an independent predictor of response to paroxetine CR. RESULTS: In logistic regression, the history of depression and/or anxiety did not predict treatment response as measured by >or=25% reduction in Fibromyalgia Impact Questionnaire (FIQ) score (OR=0.66, 95% CI=.29-1.49, Wald=0.97, p=0.32), while the drug status (paroxetine CR) was significantly associated with treatment response (OR=2.57, CI=1.2-5.61, Wald=5.5, p=0.02). CONCLUSION: A significant proportion of patients with fibromyalgia had a history of anxiety and or depressive disorders. However response to treatment of fibromyalgia symptoms with paroxetine CR was not associated with a history of depressive and/or anxiety disorders. Our findings need to be confirmed in more adequately-powered and well-designed subsequent studies.

History of early abuse as a predictor of treatment response in patients with fibromyalgia: a post-hoc analysis of a 12-week, randomized, double-blind, placebo-controlled trial of paroxetine controlled release.

OBJECTIVES: We conducted a post-hoc analysis to determine whether a history of physical or sexual abuse was associated with response to treatment in a double-blind, randomized, placebo-controlled trial of paroxetine controlled release (CR) in fibromyalgia. METHODS: A randomized, double-blind, placebo-controlled trial of paroxetine controlled release (CR) (dose 12.5-62.5 mg/day) was conducted in patients with fibromyalgia for 12 weeks. A total of 112 subjects provided complete information on childhood history of abuse that was recorded using the Sexual and Physical Abuse Questionnaire and randomized to treatments. Outcome evaluations in the abuse subgroup were identical to those in the entire sample. Health Status was determined using the 36-Item Short Form Health Survey (SF-36), the Sheehan Disability Scale (SDS), and the Perceived Stress Scale (PSS). Fibromylagia symptom severity was determined using the Fibromyalgia Impact Questionnaire (FIQ) and the Visual Analogue Scale for Pain (VAS). The primary outcome was treatment response defined as > or = 25% reduction in the FIQ-total score. Secondary outcomes include changes in scores on the Clinical Global Impression-Severity and Improvement (CGI-S and CGI-I respectively) and SF-36. RESULTS: The rate of childhood physical and/or sexual abuse was 52.7% (n=59). The baseline characteristics (health status, perceived stress, symptom severity) were not associated with abuse history. In logistic regression, the history of abuse did not predict treatment response as measured by > or = 25% reduction in FIQ-total score (OR = 1.16, 95% CI = 1.18-1.60, P = 0.35), while the drug status (paroxetine CR) was significantly associated with treatment response (OR = 2.51, 95% CI = 1.12-5.64, P = 0.02). Abuse history did not predict CGI-I (P = 0.32) or CGI-S (P = 0.74) improvements during treatment. After 12 weeks of treatment, subjects with sexual abuse history showed significantly lower mean change in health status (SF-36) than those without sexual abuse history (P = 0.04). CONCLUSIONS: Although, a significant proportion of patients with fibromyalgia reported a history of abuse, it does not appear to have any significant clinical correlates at baseline. History of abuse did not predict response to treatment in patients with fibromyalgia participating in a controlled trial of paroxetine controlled release. Prospective, well-designed studies are needed to confirm whether selective serotonin uptake inhibitors are effective in patients with fibromyalgia irrespective of their abuse history.

Polypharmacy in pregnant women with major psychiatric illness: a pilot study.

OBJECTIVE: There is increasing concern about the use of multiple medications in populations with psychiatric illnesses. One large study reported that 99% of pregnant women had received a prescription for at least one medication during pregnancy, with a mean of 13.6 medications per woman. The present descriptive study examined patterns of medication use across pregnancy in a low socioeconomic status population of women who had a psychiatric illness as a primary diagnosis. METHOD: Data on 115 pregnant women were extracted from a Medicaid Database of 5,000 women who received prenatal and other medical care over a 2-year period (2002-2004). Subjects included women with bipolar disorder, schizoaffective disorder, and schizophrenia. Information on age, diagnoses, dates prescriptions were filled, and type, dose, and quantity of medications was recorded in the database. RESULTS: Data were collected on 115 pregnancies; complete data throughout pregnancy were available for 75 women, while data on certain gestational months were available for the other 40 women. A majority of the 115 women were diagnosed with bipolar or schizoaffective disorder. Their mean age was 26 years. The mean number of medications taken during pregnancy was three (range 0-10; mode = 3); 26.8% of the pregnant women filled prescriptions for 6-10 medications during their pregnancy. No dose changes were made for the prescribed medications to accommodate changing metabolism across pregnancy. The most frequently prescribed medications for these psychiatrically ill women were from the opiate family. CONCLUSIONS: Multiple medications are frequently prescribed to pregnant women with psychiatric disorders because of comorbid diagnoses. However, the effects of taking multiple psychotropic or other medications during pregnancy on pregnancy outcome and fetal development are unknown. Therefore, more research is needed concerning the effects on the developing fetus of taking multiple medications with central nervous system effects during pregnancy.

Trends in nonheroin opioid abuse admissions: 1992-2004.

AIMS: This study examines trends for treatment admissions for nonheroin opioid abuse from 1992 to 2004. METHODS: Databases from the Substance Abuse Mental Health Services Administration (SAMHSA, U.S.A.): Treatment Episode Data Set (TEDS) were used to examine the changing characteristics of admissions to treatment for nonheroin opioid abuse. Data are collected annually from each state on characteristics of admissions to treatment for all substances abused in the United States. Using the Mann-Kendall test for examining annual trends, we determined any significant trend changes by modeling data for every 2years of TEDS information from 1992 to 2004. RESULTS: We found significant changes for admissions to substance abuse treatment from 1992 to 2004. Overall, nonheroin opioid admissions to treatment have increased, specifically among adolescents. Other significant trends included an increase in the never-married group admitted, a higher rate of psychiatric problems for nonberoin opioid abuse admissions, changes in the treatment services and significant associations between age of first use of marijuana and methamphetamine, and subsequent nonheroin opioid abuse admissions. CONCLUSION: Characteristics of admissions to treatment are changing over time and identify an admitted treatment group that is historically different from heroin abusers. These findings will give providers information about who is seeking treatment for nonheroin opiate abuse. Altered treatment strategies that target the changing population who seek treatment for nonheroin opioid abuse need to be universally available.

A randomized, controlled, trial of controlled release paroxetine in fibromyalgia.

PURPOSE: We investigated the efficacy and tolerability of paroxetine controlled release, a selective serotonin reuptake inhibitor in fibromyalgia. METHODS: After excluding patients with current major depression and anxiety disorders, 116 subjects with fibromyalgia were enrolled in a 12-week, randomized, double-blind, placebo-controlled, trial of paroxetine controlled release (12.5-62.5 mg/day). The primary outcome measure was proportion of responders as defined as a> or =25% reduction in scores on the Fibromyalgia Impact Questionnaire (FIQ) from randomization to end of treatment. Secondary outcome measures included changes in FIQ scores, Clinical Global Impression -Improvement (CGI-I) and Severity (CGI-S) scores, Visual Analogue Scale for pain scores, number of tender points, and scores on the Sheehan Disability Scale (SDS). RESULTS: Significantly more patients in paroxetine controlled release group (57%) showed a> or =25% reduction in FIQ compared to placebo (33%) (P=.016). Paroxetine controlled release was significantly superior to placebo in reducing the FIQ total score (P =.015). The CGI-I ratings significantly favored the drug over placebo (P<.005). The improvements on other secondary outcome measures between the 2 groups were not statistically significant. Drowsiness, dry mouth, blurred vision, genital disorders, and anxiety were reported more frequently with paroxetine controlled release. The mean dose of paroxetine controlled release was 39.1 mg/day. CONCLUSIONS: Paroxetine controlled release appears to be well-tolerated and improve the overall symptomatology in patients with fibromyalgia without current mood or anxiety disorders. However, its effect on pain measures seems to be less robust.

Relationship of prolactin response to meta-chlorophenylpiperazine with severity of drug use in cocaine dependence.

RATIONALE: Serotonergic (5-HT) mechanisms appear to mediate central effects of cocaine. Therefore 5-HT disturbances could be associated with drug severity. OBJECTIVES: We investigated whether prolactin (PRL) response to meta-chlorophenylpiperazine (m-CPP), a mixed 5-HT agonist/antagonist were associated with severity of cocaine use. METHODS: Thirty-six cocaine-dependent subjects and 33 controls underwent a challenge with 0.5 mg/kg of oral m-CPP. Severity of drug use was assessed using the Addiction Severity Index (ASI). RESULTS: The PRL response to m-CPP was significantly blunted in cocaine patients compared to controls (F = 21.86, p < 0.001). DeltaPRL (peak PRL-baseline PRL) was negatively correlated with ASI-drug (r = -0.45, p < 0.01), ASI-alcohol (r = -0.32, p < 0.05), and ASI-psychological (r = -0.41, p < 0.01) composite scores, and with the quantity, frequency and duration of drug use (r ranged from - 0.41 to - 0.32, p ranged from < 0.01 to 0.05). Hierarchical regressions showed that ASI-drug composite scores significantly predicted the variance in DeltaPRL after controlling for behavioral and demographic variables (F = 4.27, p < 0.05). CONCLUSIONS: The results indicate that disturbances in 5-HT function as reflected by a blunted response to m-CPP seem to be primarily associated with severity of drug use and to a lesser, although significant extent with behavioral traits in cocaine-dependent patients.

Changes in tobacco smoking following treatment for cocaine dependence.

Incorporation of smoking cessation into cocaine treatment programs remains a challenge. A major concern is that cocaine abusers may tend to substitute one drug for the other. If this is true, successful treatment of cocaine abuse should lead to an increase in tobacco smoking. We compared tobacco smoking at admission, end of treatment and 9-month follow up for 168 crack cocaine dependent patients entering a 12-week outpatient treatment program for substance abuse. Smoking cessation was not a part of treatment. As expected cocaine patients improved with treatment and showed significant reduction in scores on the Addiction Severity Index (ASI). There were no significant changes in number of cigarettes smoked per day or scores on the Fagerstrom Test for Nicotine dependence (FTND) from baseline to end of treatment or follow-up. Also, there were no differences in the proportions of nonsmokers and smokers who changed their smoking habits over the treatment and follow up period. At follow up subjects who were abstinent as well as those using cocaine showed no changes in tobacco smoking. There is no evidence that reduction in crack cocaine smoking following treatment is accompanied by an increase in tobacco smoking. It appears that concerns over tobacco being substituted for cocaine may be unfounded in this population.