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Biomedical subjects

R S Schottenfeld

Publications and source records attributed to R S Schottenfeld.

At least 19 recordsLinked to original sources
PubMed2001

Methadone maintenance in primary care: a randomized controlled trial.

CONTEXT: Methadone maintenance is an effective treatment for opioid dependence, yet its use is restricted to federally licensed narcotic treatment programs (NTPs). Office-based care of stabilized methadone maintenance patients is a promising alternative but no data are available from controlled trials regarding this type of program. OBJECTIVE: To determine the feasibility and efficacy of office-based methadone maintenance by primary care physicians vs in an NTP for stable opioid-dependent patients. DESIGN: Six-month, randomized controlled open clinical trial conducted February 1999-March 2000. SETTING: Offices of 6 primary care internists and an NTP. PATIENTS: Forty-seven opioid-dependent patients who had been receiving methadone maintenance therapy in an NTP without evidence of illicit drug use for 1 year and without significant untreated psychiatric comorbidity were randomized; 1 patient refused to participate after treatment assignment to NTP. INTERVENTIONS: Patients were randomly assigned to receive office-based methadone maintenance from primary care physicians, who received specialized training in the care of opioid-dependent patients (n = 22), or usual care at an NTP (n = 24). MAIN OUTCOME MEASURES: Illicit drug use, clinical instability (persistent drug use), patient and clinician satisfaction, functional status, and use of health, legal, and social services, compared between the 2 groups. RESULTS: Eleven of 22 (50%; 95% confidence interval [CI], 29%-71%) patients in office-based care compared with 9 of 24 (38%; 95% CI, 21%-57%) of NTP patients had a self-report or urine toxicology test result indicating illicit opiate use (P =.39). Hair toxicology testing detected an additional 2 patients in each treatment group with evidence of illicit drug use, but this did not change the overall findings. Ongoing illicit drug use meeting criteria for clinical instability occurred in 4 of 22 (18%; 95% CI, 7%-39%) patients in office-based care compared with 5 of 24 (21%; 95% CI, 9%-41%) NTP patients (P =.82). Sixteen of the 22 (73%; 95% CI, 54%-92%) office-based patients compared with 3 of the 24 (13%; 95% CI, 0%-26%) NTP patients thought the quality of care was excellent (P =.001). There were no differences over time within or between groups in functional status or use of health, legal, or social services. CONCLUSIONS: Our results support the feasibility and efficacy of transferring stable opioid-dependent patients receiving methadone maintenance to primary care physicians' offices for continuing treatment and suggest guidelines for identifying patients and clinical monitoring.

Adult↗
PubMed2000

Thrice-weekly versus daily buprenorphine maintenance.

BACKGROUND: Buprenorphine is a promising alternative to methadone or levo-acetyl alpha methadol for opioid agonist maintenance treatment, and thrice-weekly dosing would facilitate its use for this purpose. METHODS: After a 3-day induction, opioid-dependent patients (n = 92) were randomly assigned to daily clinic attendance and 12-weeks maintenance treatment with sublingual buprenorphine administered double blind either daily (n = 45; 16 mg/70 kg) or thrice weekly (n = 47; 34 mg/70 kg on Fridays and Sundays and 44 mg/70 kg on Tuesdays). Outcome measures include retention, results of 3x/week urine toxicology tests, and weekly self-reported illicit drug use. RESULTS: There were no significant differences at baseline in important social, demographic, and drug-use features. Retention was 71% in the daily and 77% in the 3x/week conditions. The proportion of opioid-positive urine tests decreased significantly from baseline in both groups and averaged 57% (daily) and 58% in 3x/week. There were no significant differences between groups in self-reported number of bags of heroin used for any day of the week, including Thursdays (48-72 hours following the last buprenorphine dose for subjects in the 3x/week condition), or in medication compliance (92%, 91%) and counseling attendance (82%, 82%). CONCLUSIONS: At an equivalent weekly dose of 112 mg/70 kg, thrice-weekly and daily sublingual buprenorphine appear comparable in efficacy with regard to retention and reductions in illicit opioid and other drug use. These findings support the potential for utilizing thrice-weekly buprenorphine dosing in novel settings.

Adult↗
PubMed2000

Disulfiram versus placebo for cocaine dependence in buprenorphine-maintained subjects: a preliminary trial.

BACKGROUND: We examined the effects of disulfiram versus placebo on cocaine dependence in buprenorphine-maintained subjects. METHODS: Opioid and cocaine dependent subjects (n = 20) were induced onto buprenorphine maintenance, then randomized to disulfiram (250 mg q.d. ; n = 11) or placebo (n = 9) treatment for 12 weeks. RESULTS: Groups were comparable at baseline on demographic measures and on baseline measures of drug-use severity. Fifteen subjects completed the study, including 8 subjects randomized to disulfiram (72.7%) and 7 subjects randomized to placebo (77.8%). The total number of weeks abstinent from cocaine was significantly greater on disulfiram versus placebo (mean +/- SD: 7.8 +/- 2.6 vs. 3.3 +/- 0.5, p <.05) and the number of days to achieving 3 weeks (24.6 +/- 15.1 vs. 57.8 +/- 7.7, p <.01) of continuous cocaine abstinence was significantly lower in disulfiram compared with placebo. The number of cocaine-negative urine tests during the trial were also higher on disulfiram (14.7) than on placebo (8.6); furthermore, subjects in the disulfiram group achieved consistently higher rates of cocaine-negative urine tests in each 3-week interval and the increase over time was faster in the disulfiram compared with placebo. CONCLUSIONS: This preliminary study suggests the potential efficacy of disulfiram versus placebo for treatment of cocaine dependence in buprenorphine-maintained patients.

Adult↗
PubMed2000

Community reinforcement approach for combined opioid and cocaine dependence. Patterns of engagement in alternate activities.

We compared outcomes for agonist-maintained patients with combined opioid and cocaine dependence who were treated in an earlier clinical trial with group drug counseling (DC; n = 57) or in a current trial with the Community Reinforcement Approach (CRA; n = 60). The association between engagement in nondrug-related activities and abstinence was also evaluated. There were no significant differences between the treatments in retention or drug use. The total number of hours and average hours per week engaged in nondrug-related activities was significantly higher for CRA-treated patients who achieved abstinence from opioids, cocaine, or both combined than for those who never achieved abstinence. Although CRA was not more effective overall than DC, the finding that engagement in reinforcing community activities unrelated to drug use (e.g., planned pleasurable events or parenting activities) was associated with abstinence suggests that the planning and reinforcement of specific nondrug-related social, vocational, and recreational activities is a crucial component of CRA.

Adult↗
PubMed1999

Plasma concentrations of buprenorphine 24 to 72 hours after dosing.

BACKGROUND: This study evaluated plasma buprenorphine concentrations 24-72 h following sublingual administration of a dose of buprenorphine solution, ranging from 16 mg/70 kg to 44 mg/70 kg, administered on a daily or thrice-weekly schedule. Additionally, this study evaluated the effects of different thrice-weekly buprenorphine dose schedules on opiate use and withdrawal symptoms. METHODS: Opiate dependent subjects (n = 10) were maintained in an outpatient clinic for two 3-week periods at each of three thrice-weekly buprenorphine dose schedules (providing a weekly total buprenorphine dose of 64, 84 and 112 mg) and for 1 week of a daily buprenorphine dose of 16 mg/70 kg. Plasma samples were obtained 24, 48 and 72 h following administration of buprenorphine. Urine samples were also collected and opiate withdrawal symptoms, agonist effects and the use of heroin, cocaine, alcohol and other drugs, were assessed. RESULTS: Plasma levels showed a wide range of intra- and inter-subject variability. Nonetheless, higher doses of buprenorphine resulted in higher plasma concentrations at each time point and plasma concentration decreased with time. There were no significant differences in heroin use across dosing. Rates of withdrawal symptoms were low and did not differ across dosing schedules. CONCLUSIONS: In the two highest dose schedules, plasma levels 72 h following the administration of the highest dose and at 48 h after the lower dose, were comparable to plasma concentrations at 24 h following daily administration of 16 mg/70 kg of buprenorphine.

Administration, Sublingual↗
PubMed1998

A randomized trial of buprenorphine maintenance for heroin dependence in a primary care clinic for substance users versus a methadone clinic.

PURPOSE: Buprenorphine is an alternative to methadone for the maintenance treatment of heroine dependence and may be effective on a thrice weekly basis. Our objective was to evaluate the effect of thrice weekly buprenorphine maintenance for the treatment of heroin dependence in a primary care clinic on retention in treatment and illicit opioid use. SUBJECTS AND METHODS: Opioid-dependent patients were randomly assigned to receive thrice weekly buprenorphine maintenance in a primary care clinic that was affiliated with a drug treatment program (n = 23) or in a traditional drug treatment program (n = 23) in a 12-week clinical trial. Primary outcomes were retention in treatment and urine toxicology for opioids; secondary outcomes were opioid withdrawal symptoms and toxicology for cocaine. RESULTS: Retention during the 12-week study was higher in the primary care setting (78%, 18 of 23) than in the drug treatment setting (52%, 12 of 23; P = 0.06). Patients admitted to primary care had lower rates of opioid use based on overall urine toxicology (63% versus 85%, P < 0.01) and were more likely to achieve 3 or more consecutive weeks of abstinence (43% versus 13%, P = 0.02). Cocaine use was similar in both settings. CONCLUSIONS: Buprenorphine maintenance is an effective treatment for heroin dependence in a primary care setting.

Adult↗
PubMed1998

When is less treatment better? The role of social anxiety in matching methadone patients to psychosocial treatments.

In response to a need to match drug users to the most appropriate and cost-effective level of care, it was hypothesized the socially anxious methadone-maintained patients would attain greater benefit from coping skills training provided in the context of a low-intensity enhanced standard methadone maintenance intervention (E-STD) than in the context of a high-intensity, socially demanding day treatment program (DTP). Social anxiety was assessed in 307 methadone-maintained patients using the Social Anxiety and Distress Scale prior to randomization to either E-STD or DTP. The hypothesis was supported: Socially anxious patients were drug free longer during treatment, were more likely to be abstinent at treatment completion, and had greater reductions in HIV risk behaviors if assigned to the lower intensity intervention, which was provided at 1/3 the cost of the DTP.

Adolescent↗
PubMed1998

Prognostic factors in Buprenorphine- versus methadone-maintained patients.

This study a) compared the effects of buprenorphine versus methadone maintenance on benzodiazepine and alcohol use and b) evaluated the prognostic significance of gender and psychopathology and their interaction with maintenance treatment. Eighty male and 36 female patients were randomly assigned to daily sublingual buprenorphine (4 or 12 mg) or oral methadone (20 or 65 mg). Maintenance medication was not associated with significant differences in alcohol or benzodiazepine use. Rates of abstinence from illicit opioids were significantly higher for females, within the buprenorphine 4-mg group, females also had significantly better retention, lower rates of opioid-positive urine samples, and higher rates of abstinence from illicit opioids. Lifetime sedative dependence was associated with significantly better retention, decreased rates of cocaine-positive urine samples, and increased rates of cocaine abstinence; among buprenorphine- but not methadone-maintained patients, it was also associated with increased rates of abstinence from illicit opioids.

Adult↗
PubMed1998

Assessment of HIV risk.

Based on the review of existing instruments and analysis of problems encountered in clinical and research practice with one of the most commonly used assessment instruments, the RAB, this paper proposes a number of solutions aimed at improving validity, and efficiency of assessment of HIV risk in drug abusing populations. Briefly, five domains of assessment are discussed: intravenous drug use, high-risk sexual behaviors, knowledge of HIV transmission and methods of prevention, psychological aspects of behavioral change, and epidemiological factors of HIV transmission. The paper discusses also changes in format, scope, and context, as well as scoring procedures that may improve discriminability and sensitivity to detect change of a comprehensive HIV risk assessment instrument. Finally, a process of developing an HIV risk assessment instrument, the ARI-I, which is based on the proposed recommendations and which incorporates methodological improvements discussed in the paper is briefly described.

HIV Infections↗
PubMed1997

Three methods of opioid detoxification in a primary care setting. A randomized trial.

BACKGROUND: Opioid detoxification in a primary care setting followed by ongoing substance abuse treatment may be appropriate for selected opioid-dependent patients. OBJECTIVE: To compare three pharmacologic protocols for opioid detoxification in a primary care setting. DESIGN: Randomized, double-blind clinical trial with random assignment to treatment protocols. SETTING: A free-standing primary care clinic affiliated with drug treatment programs. PATIENTS: 162 heroin-dependent patients. INTERVENTIONS: Three detoxification protocols: donidine, combined donidine and naltrexone, and buprenorphine. MEASUREMENTS: Successful detoxification (that is, when study participants received a full opioid-blocking dose [50 mg] of naltrexone), treatment retention (8 days), and withdrawal symptoms. RESULTS: Overall, 65% of participants (36 of 55) who received clonidine, 81% (44 of 54) who received combined clonidine and naltrexone, and 81% (43 of 53) who received buprenorphine were successfully detoxified. Retention did not differ significantly across the groups: 65% of participants (36 of 55) who received clonidine, 54% (29 of 54) who received combined clonidine and naltrexone, and 60% (32 of 53) who received buprenorphine. Participants who received buprenorphine had a significantly lower mean withdrawal symptom score than those who received clonidine or combined clonidine and naltrexone. CONCLUSIONS: Participants in the combined clonidine and naltrexone group and those in the buprenorphine group were more likely to complete detoxification, although retention at 8 days did not differ among the groups. Participants who were assigned to the buprenorphine group experienced less severe withdrawal symptoms than those assigned to the other two groups.

Adolescent↗
PubMed1997

Buprenorphine vs methadone maintenance treatment for concurrent opioid dependence and cocaine abuse.

BACKGROUND: Buprenorphine, a partial mu-agonist and kappa-antagonist, has been proposed as an alternative to methadone for maintenance treatment of opioid dependence, especially for patients with concurrent cocaine dependence or abuse. This study evaluated whether higher maintenance doses of buprenorphine and methadone are superior to lower doses for reducing illicit opioid use and whether buprenorphine is superior to methadone for reducing cocaine use. METHODS: A total of 116 subjects were randomly assigned to 1 of 4 maintenance treatment groups involving higher or lower daily doses of sublingual buprenorphine (12 or 4 mg) or methadone (65 or 20 mg) in a double-blind, 24-week clinical trial. Outcome measures included retention in treatment and illicit opioid and cocaine use as determined by urine toxicology testing and self-report. RESULTS: There were significant effects of maintenance treatment on rates of illicit opioid use, but no significant differences in treatment retention or the rates of cocaine use. The rates of opioid-positive toxicology tests were lowest for treatment with 65 mg of methadone (45%), followed by 12 mg of buprenorphine (58%), 20 mg of methadone (72%), and 4 mg of buprenorphine (77%), with significant contrasts found between 65 mg of methadone and both lower-dose treatments and between 12 mg of buprenorphine and both lower-dose treatments. CONCLUSIONS: The results support the superiority of higher daily buprenorphine and methadone maintenance doses vs lower doses for reducing illicit opioid use, but the results do not support the superiority of buprenorphine compared with methadone for reducing cocaine use.

Adult↗
PubMed1997

A five-factor model of personality and addiction, psychiatric, and AIDS risk severity in pregnant and postpartum cocaine misusers.

The relationship between addiction severity, psychiatric symptoms, AIDS risk behaviors, and an alternative five-factor measure of personality, the Zuckerman-Kuhlman Personality Questionnaire, was assessed in 92 cocaine-misusing pregnant and postpartum women in an inner city outpatient treatment program. Three of the personality traits (Neuroticism-Anxiety, Impulsive Sensation Seeking, Aggression-Hostility) were significantly related to different subscales of the Addiction Severity Index, Beck Depression Inventory, various psychiatric symptoms, and high HIV risk sexual activity. Of these traits, Neuroticism-Anxiety seemed to be the most powerful predictor of symptom severity for this sample of women. Scores on the personality dimensions were not related to recency, frequency, amount, or duration of drug use or to treatment outcomes.

Acquired Immunodeficiency Syndrome↗
PubMed1997

Maternal attentiveness of cocaine abusers during child-based assessments.

Cocaine-abusing mothers were compared with non-cocaine-using mothers on videotaped ratings of attentiveness to their children during developmental assessments done at age 3 months (n = 64), 6 months (n = 80), 12 months (n = 90), and 18 months (n = 53). At the 3-month assessment only, cocaine-abusing women spent a lower percentage of time being attentive and made more shifts in attentiveness than did control-group mothers. These differences were not found at 6-, 12-, or 18-month assessments. Maternal attentiveness appears to be more strongly related to current depression symptoms than addiction severity in the cocaine-abusing group.

Adult↗
PubMed1996

Naltrexone, relapse prevention, and supportive therapy with alcoholics: an analysis of patient treatment matching.

Alcohol-dependent patients (N = 97) were randomly assigned to receive either naltrexone or placebo and either relapse prevention therapy or supportive therapy. The present report explored the hypothesis that patients could be matched to the above treatments on the basis of specific pretreatment characteristics. Treatment matching variables explored included craving, alcohol dependence severity, and cognitive measures of learning and memory. Results of linear regression analyses tentatively suggest that patients experiencing higher levels of craving and poorer cognitive functioning may derive the greatest benefit from naltrexone versus placebo. For psychotherapy, lower levels of verbal learning were associated with poorer drinking outcomes for relapse prevention therapy but not for supportive therapy. Conversely, higher levels of verbal learning were associated with better outcomes for relapse prevention therapy but not for supportive therapy.

Adolescent↗
PubMed1996

A database model for studies of cocaine-dependent pregnant women and their families.

The database management functions for the Mothers Project are arranged into administrative and analytic task groups, and separate systems are devised for each. The task groups can be distinguished not only by differences in data structure but also by interface requirements. The administrative database system uses a relational database technology, whereas the analytic database system employs more traditional flat-file methods. Although the database management systems are complex, they are based on standard database practices, used in widely available software packages, and run on inexpensive desktop computing equipment.

Cocaine↗
PubMed1995

Primary care-based ambulatory opioid detoxification: the results of a clinical trial.

OBJECTIVE: To determine the feasibility of primary care-based ambulatory opioid detoxification (AOD) using two protocols: clonidine and clonidine plus naltrexone. SETTING: The Central Medical Unit (CMU)--a freestanding primary care medical clinic staffed by physicians and nurse practitioners. PATIENTS: Injection drug users (IDUs) seeking substance abuse treatment between the ages of 18 and 50 years who were addicted to opioids (e.g., heroin) and not currently in drug treatment. INTERVENTIONS: In the clonidine protocol, clonidine was administered every 4 hours "as needed" for up to 12 days. In the clonidine plus naltrexone protocol, clonidine was administered and naltrexone was administered in increasing doses over five days. Both protocols included "adjuvant" medications for muscle cramps, insomnia, and vomiting. Successfully detoxified patients were referred to ongoing drug treatment. DESIGN: A prospective nonrandomized clinical trial. MEASUREMENTS AND MAIN RESULTS: One hundred forty opioid-addicted IDUs were referred to the medical clinic for AOD. Among the 125 patients who enrolled in the study, 57 selected clonidine and 68 selected clonidine/naltrexone. The treatment groups (clonidine vs clonidine/naltrexone) were similar at baseline with respect to: age at first heroin use (21 years vs 23 years), mean admission opioid craving score (45/100 vs 49/100), and withdrawal symptom score (19/72 vs 18/72). Overall, 70% (88/125) of the AODs were successful, including 42% (24/57) for clonidine and 94% (64/68) for clonidine/naltrexone (p < 0.001). CONCLUSIONS: This study suggests that primary care-based AOD can be safely and effectively carried out by primary care providers and that clonidine/naltrexone may be more effective in this setting than is clonidine alone. Ambulatory opioid detoxification can give internists a larger role in initiating drug treatment for IDUs who are addicted to opioids.

Adolescent↗