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Biomedical subjects

Herbert D Kleber

Publications and source records attributed to Herbert D Kleber.

At least 19 recordsLinked to original sources
PubMed2006

Injectable, sustained-release naltrexone for the treatment of opioid dependence: a randomized, placebo-controlled trial.

CONTEXT: Oral naltrexone can completely antagonize the effects produced by opioid agonists. However, poor compliance with naltrexone has been a major obstacle to the effective treatment of opioid dependence. OBJECTIVE: To evaluate the safety and efficacy of a sustained-release depot formulation of naltrexone in treating opioid dependence. DESIGN AND SETTING: Randomized, double-blind, placebo-controlled, 8-week trial conducted at 2 medical centers. PARTICIPANTS: Sixty heroin-dependent adults. INTERVENTIONS: Participants were stratified by sex and years of heroin use (> or = 5 vs < 5) and then were randomized to receive placebo or 192 or 384 mg of depot naltrexone. Doses were administered at the beginning of weeks 1 and 5. All participants received twice-weekly relapse prevention therapy, provided observed urine samples, and completed other assessments at each visit. MAIN OUTCOME MEASURES: Retention in treatment and percentage of opioid-negative urine samples. RESULTS: Retention in treatment was dose related, with 39%, 60%, and 68% of patients in the placebo, 192 mg of naltrexone, and 384 mg of naltrexone groups, respectively, remaining in treatment at the end of 2 months. Time to dropout had a significant main effect of dose, with mean time to dropout of 27, 36, and 48 days for the placebo, 192 mg of naltrexone, and 384 mg of naltrexone groups, respectively. The percentage of urine samples negative for opioids, methadone, cocaine, benzodiazepines, and amphetamine varied significantly as a function of dose. When the data were recalculated without the assumption that missing urine samples were positive, a main effect of group was not found for any drugs tested except cocaine, where the percentage of cocaine-negative urine samples was lower in the placebo group. Adverse events were minimal and generally mild. This formulation of naltrexone was well tolerated and produced a robust, dose-related increase in treatment retention. CONCLUSION: These data provide new evidence of the feasibility, efficacy, and tolerability of long-lasting antagonist treatments for opioid dependence.

Adolescent↗
PubMed2006

Behavioral therapy to augment oral naltrexone for opioid dependence: a ceiling on effectiveness?

The effectiveness of antagonist maintenance with oral naltrexone for opioid dependence has been limited by high dropout rates. Behavioral Naltrexone Therapy (BNT) was developed to improve retention on oral naltrexone by integrating voucher incentives, Motivational and Cognitive Behavioral therapies, and a significant other for monitoring medication adherence. In a 6-month, randomized, controlled trial in heroin dependent patients, BNT (N = 36) improved retention in treatment compared to a standard treatment control (Compliance Enhancement (CE); N = 33) (log rank = 4.28; p = .04). Most patients retained beyond 3 months achieved abstinence from opioids, but retention at 6 months was only 22% on BNT and 9% on CE. A systematic review of related controlled trials revealed similar effect sizes in the small to medium range, and substantial dropout. There may be a limit on the extent to which behavioral therapy can overcome poor adherence to oral naltrexone. Future research should consider combinations of behavioral methods with new long-acting injectable or implantable naltrexone formulations.

Behavior Therapy↗
PubMed2006

Evaluation of a combined online and in person training in the use of buprenorphine.

To evaluate buprenorphine training methodology, we surveyed physicians who had completed a combined online and in person buprenorphine curriculum. Of 53/70 (76%) survey respondents, 57% were psychiatrists and 40% generalists. On a scale of 1 (very poor) to 7 (superlative), the overall training rated a mean of 5.8. The online course (5.0) rated lower than in person training components (p < .001) except for material that addressed the logistics of office practice. The in person patient interview received the highest rating (mean 6.3, p < .001). The 67% of physicians who intended to prescribe buprenorphine after the training were more likely than hesitant physicians to agree that the course provided enough information (p < .05) and that telephone access to experienced providers would improve their confidence (p < .05). Physicians hesitant to prescribe cited lack of experience as the main barrier (41%), with 24% concerned about induction difficulty and reimbursement. Overall, physicians preferred in person instruction and may benefit from additional experiential training and support after curriculum participation.

Adult↗
PubMed2005

Response to cocaine, alone and in combination with methylphenidate, in cocaine abusers with ADHD.

Attention deficit hyperactivity disorder (ADHD) is prevalent in adult cocaine abusers. Yet, it remains to be determined how the response to cocaine differs in cocaine abusers with ADHD compared to cocaine abusers without ADHD. Further, since ADHD is commonly treated with stimulants, such as methylphenidate (MPH), it is important to examine whether MPH maintenance alters the response to cocaine in cocaine abusers with ADHD. Thus, the first phase of this study compared the response to cocaine in adult cocaine abusers with ADHD to those without ADHD. The second phase assessed the effects of oral sustained-release methylphenidate (MPH-SR) maintenance (40 and 60 mg) on the response to cocaine only in those with ADHD. Cocaine abusers with ADHD (N=7) and without ADHD (N=7) who were not seeking treatment remained inpatient initially for 1 week, when the effects of cocaine alone were tested (Phase 1). Cocaine abusers with ADHD remained inpatient for an additional 3 weeks, during which the effects of cocaine during oral MPH-SR maintenance were tested (Phase 2). During cocaine fixed dosing sessions, participants received four injections of i.v. cocaine (0, 16 or 48 mg/70 kg), spaced 14 min apart. During cocaine choice sessions, participants had a choice between receiving i.v. cocaine (16 or 48 mg/70 kg) or two tokens, each exchangeable for 2 US dollars. Subjective effects related to ADHD symptoms (e.g. ratings of "Able to Concentrate") were significantly lower in cocaine abusers with ADHD compared to those without ADHD when placebo cocaine was administered. Active cocaine produced similar increases in cardiovascular and positive subjective effects in both groups and there was no difference in cocaine choice between the two groups. These data suggest that the response to cocaine is not different between cocaine abusers with ADHD compared to those without ADHD. When the cocaine abusers with ADHD were maintained on MPH-SR, cardiovascular effects were increased, however, this did not warrant termination of any test session. Maintenance on MPH-SR decreased some of the positive subjective effects of cocaine. Further, maintenance on a high dose of MPH-SR decreased cocaine choice. Thus, oral MPH-SR is safe in combination with repeated cocaine doses and decreases some of the positive and reinforcing effects of cocaine in cocaine abusers with ADHD.

Administration, Oral↗
PubMed2005

Anesthesia-assisted vs buprenorphine- or clonidine-assisted heroin detoxification and naltrexone induction: a randomized trial.

CONTEXT: Rapid opioid detoxification with opioid antagonist induction using general anesthesia has emerged as an expensive, potentially dangerous, unproven approach to treat opioid dependence. OBJECTIVE: To determine how anesthesia-assisted detoxification with rapid antagonist induction for heroin dependence compared with 2 alternative detoxification and antagonist induction methods. DESIGN, SETTING, AND PATIENTS: A total of 106 treatment-seeking heroin-dependent patients, aged 21 through 50 years, were randomly assigned to 1 of 3 inpatient withdrawal treatments over 72 hours followed by 12 weeks of outpatient naltrexone maintenance with relapse prevention psychotherapy. This randomized trial was conducted between 2000 and 2003 at Columbia University Medical Center's Clinical Research Center. Outpatient treatment occurred at the Columbia University research service for substance use disorders. Patients were included if they had an American Society of Anesthesiologists physical status of I or II, were without major comorbid psychiatric illness, and were not dependent on other drugs or alcohol. INTERVENTIONS: Anesthesia-assisted rapid opioid detoxification with naltrexone induction, buprenorphine-assisted rapid opioid detoxification with naltrexone induction, and clonidine-assisted opioid detoxification with delayed naltrexone induction. MAIN OUTCOME MEASURES: Withdrawal severity scores on objective and subjective scales; proportions of patients receiving naltrexone, completing inpatient detoxification, and retained in treatment; proportion of opioid-positive urine specimens. RESULTS: Mean withdrawal severities were comparable across the 3 treatments. Compared with clonidine-assisted detoxification, the anesthesia- and buprenorphine-assisted detoxification interventions had significantly greater rates of naltrexone induction (94% anesthesia, 97% buprenorphine, and 21% clonidine), but the groups did not differ in rates of completion of inpatient detoxification. Treatment retention over 12 weeks was not significantly different among groups with 7 of 35 (20%) retained in the anesthesia-assisted group, 9 of 37 (24%) in the buprenorphine-assisted group, and 3 of 34 (9%) in the clonidine-assisted group. Induction with 50 mg of naltrexone significantly reduced the risk of dropping out (odds ratio, 0.28; 95% confidence interval, 0.15-0.51). There were no significant group differences in proportions of opioid-positive urine specimens. The anesthesia procedure was associated with 3 potentially life-threatening adverse events. CONCLUSION: These data do not support the use of general anesthesia for heroin detoxification and rapid opioid antagonist induction.

Adult↗
PubMed2005

Telescoping of drinking-related behaviors: gender, racial/ethnic, and age comparisons.

OBJECTIVE: To examine demographic differences in alcohol telescoping-the rate of self-reported movement from regular alcohol consumption to the onset of regular heavy drinking-as well as differences in ages of initiation of regular alcohol use and alcohol use to intoxication. METHOD: The present study compared the retrospective reports of 2037 clients (1252 males, 785 females) enrolled in substance user treatment facilities around the country in 1998 and 1999. RESULTS: Overall, the findings support previous research, indicating that women generally move more rapidly than men from initiation of regular alcohol use to problem use (telescoping). The findings also indicate that African-Americans generally begin regular alcohol use later than their Anglo counterparts and move more rapidly from initiation of regular alcohol use to problem use (telescoping). Examining the sample by older vs. younger age groups demonstrates that gender and racial/ethnic differences in the age of initiation of regular alcohol use and in telescoping may be limited by age group, as these patterns appear in the older but not the younger cohort. CONCLUSIONS: These findings suggest that self-reported regular alcohol use, alcohol abuse, and telescoping differences vary dramatically by gender, race/ethnicity, and age cohort. Furthermore, the pattern of findings suggests that these differences are more likely the result of sociocultural than biological differences between the groups under study.

Adult↗
PubMed2004

Cocaine dependence and d2 receptor availability in the functional subdivisions of the striatum: relationship with cocaine-seeking behavior.

Striatal dopamine D2 receptors have been implicated in the neurobiology of cocaine addiction. Previous imaging studies showed reduced striatal D2 receptor availability in chronic cocaine abusers, and animal studies suggested that low D2 receptor availability promotes cocaine self-administration. Here, D2 receptor availability was assessed with positron emission tomography (PET) and [11C]raclopride in the limbic, associative, and sensori-motor subdivisions of the striatum in 17 recently detoxified chronic cocaine-dependent (CCD) subjects and 17 matched healthy control (HC) subjects. In addition, the relationship between regional D2 receptor availability and behavioral measures obtained in cocaine self-administration sessions was investigated in CCD subjects. [11C]Raclopride binding potential was significantly reduced by 15.2% in the limbic striatum, 15.0% in the associative striatum, and 17.1% in the sensori-motor striatum in CCD subjects compared to HC subjects. In CCD subjects, no relationship was detected between D2 availability in striatal regions and either the positive effects of smoked cocaine or the choice of cocaine over an alternative reinforcer (money) following a priming dose of cocaine (a laboratory model of relapse). Thus, this study confirms previous reports of a modest decrease in D2 receptor availability in CCD subjects, and establishes that this decrease is generalized throughout the striatum. However, this study failed to demonstrate a relationship between D2 receptor availability and cocaine-induced cocaine-taking behavior. Additional research is warranted to unravel potential neurobiological traits that might confer vulnerability to relapse in detoxified CCD subjects.

Adult↗
PubMed2004

Identifying United States substance abuse treatment programs: a test in one mid-sized city.

An accurate national listing of substance abuse treatment programs is essential for reporting data about the nation's treatment system and the clients entering that system. The National Survey of Substance Abuse Treatment Services (NSSATS) is thought to provide the most comprehensive list of treatment providers. Therefore, we report a partial test of the concurrent validity of the NSSATS in a single mid-sized city. Using operational definitions of "substance abuse treatment" and "substance abuse treatment programs" derived from prior work by the Center for Substance Abuse Treatment; and working within the defined geographic boundaries of a single, mid-sized city, we compared the NSSATS list with an independently developed compilation of programs from 5 sources: (1) the Yellow Pages; (2) the Internet Infospace Directory; (3) a State directory of licensed substance abuse treatment services; (4) the Office of Applied Studies Directory; (5) the National Master Facility Inventory. With all sources, including NSSATS, we identified 96 separate listings that met the operational definition of adult treatment within the geographic bounds of the city. The NSSATS identified 70 of those 96 programs (73%), the 5-source compilation identified a sample of 83 (86%). While these findings from a single city cannot be considered a full test of the validity of the NSSATS, the data presented offer at least one partial but promising indication that the NSSATS may be a valid national listing and may serve as satisfactory national frame.

Adolescent↗
PubMed2003

Pharmacologic treatments for heroin and cocaine dependence.

Given the difficulty of achieving sustained recovery, pharmacotherapy of opioid and cocaine addiction is more effective when combined with behavioral and psychosocial approaches. Effective pharmacotherapies for opioid dependence and withdrawal include methadone, L-alpha acetylmethadol (LAAM), naltrexone, buprenorphine, and clonidine. Treatment of cocaine addiction includes anti-craving agents, dopamine agonists or blocking agents, antidepressants, and treatment of co-morbid psychiatric disorders, but all with mixed results. In this paper, we discuss the use of medication in the context of general principles of opioid and cocaine addiction treatment. Both established medications and promising directions in pharmacotherapy will be addressed.

Buprenorphine↗
PubMed2002

Acupuncture for the treatment of cocaine addiction: a randomized controlled trial.

CONTEXT: Auricular acupuncture is widely used to treat cocaine addiction in the United States and Europe. However, evidence from controlled studies regarding this treatment's effectiveness has been inconsistent. OBJECTIVE: To investigate the effectiveness of auricular acupuncture as a treatment for cocaine addiction. DESIGN: Randomized, controlled, single-blind clinical trial conducted from November 1996 to April 1999. SETTING: Six community-based clinics in the United States: 3 hospital-affiliated clinics and 3 methadone maintenance programs. PATIENTS: Six hundred twenty cocaine-dependent adult patients (mean age, 38.8 years; 69.2% men); 412 used cocaine only and 208 used both opiates and cocaine and were receiving methadone maintenance. INTERVENTION: Patients were randomly assigned to receive auricular acupuncture (n = 222), a needle-insertion control condition (n = 203), or a relaxation control condition (n = 195). Treatments were offered 5 times weekly for 8 weeks. Concurrent drug counseling was also offered to patients in all conditions. MAIN OUTCOME MEASURES: Cocaine use during treatment and at the 3- and 6-month postrandomization follow-up based on urine toxicology screens; retention in treatment. RESULTS: Intent-to-treat analysis of urine samples showed a significant overall reduction in cocaine use (odds ratio, 1.40; 95% confidence interval, 1.11-1.74; P =.002) but no differences by treatment condition (P =.90 for acupuncture vs both control conditions). There were also no differences between the conditions in treatment retention (44%-46% for the full 8 weeks). Counseling sessions in all 3 conditions were poorly attended. CONCLUSIONS: Within the clinical context of this study, acupuncture was not more effective than a needle insertion or relaxation control in reducing cocaine use. Our study does not support the use of acupuncture as a stand-alone treatment for cocaine addiction or in contexts in which patients receive only minimal concurrent psychosocial treatment. Research will be needed to examine acupuncture's contribution to addiction treatment when provided in an ancillary role.

Acupuncture, Ear↗
PubMed2002

Behavioral naltrexone therapy: an integrated treatment for opiate dependence.

Treatment of opiate dependence with naltrexone has been limited by poor compliance. Behavioral Naltrexone Therapy (BNT) was developed to promote adherence to naltrexone and lifestyle changes supportive of abstinence, by incorporating components from empirically validated treatments, including Network Therapy with a significant other to monitor medication compliance, the Community Reinforcement Approach, and voucher incentives. An overview is presented of the BNT treatment manual. In an uncontrolled Stage I trial (N = 47), 19% completed the 6-month course of treatment. Retention was especially poor in the subsample of patients who were using methadone at baseline (N = 18; 39% completed 1 month, none completed 6 months), and more encouraging among heroin-dependent patients (N = 29; 65% completed 1 month, 31% completed 6 months). Thus, attrition continues to be a serious problem for naltrexone maintenance, although further efforts to develop interventions such as BNT are warranted.

Adult↗