Arthur Margolin

A randomized clinical trial of a manual-guided risk reduction intervention for HIV-positive injection drug users.

This study randomized 90 HIV-seropositive, methadone-maintained injection drug users (IDUs) to an HIV Harm Reduction Program (HHRP+) or to an active control that included harm reduction components recommended by the National AIDS Demonstration Research Project. The treatment phase lasted 6 months, with follow-ups at 6 and 9 months after treatment entry. Patients in both treatments showed reductions in risk behaviors. However, patients assigned to HHRP+ were less likely to use illicit opiates and were more likely to adhere to antiretroviral medications during treatment; at follow-up, they had lower addiction severity scores and were less likely to have engaged in high risk behavior. Findings suggest that enhancing methadone maintenance with an intervention targeting HIV-seropositive IDUs increases both harm reduction and health promotion behaviors.

A multicenter trial of bupropion for cocaine dependence in methadone-maintained patients.

We conducted a multi-site, placebo-controlled, randomized double-blind clinical trial comparing bupropion HCL (300 mg/day) to placebo for the treatment of cocaine dependence in methadone-maintained subjects. A total of 149 subjects at three sites participated in a 12-week study. Outcome measures included cocaine use, level of depression, and psychosocial functioning. Results showed no significant differences between placebo and bupropion. Exploratory analyses suggested a medication effect for the subset of subjects depressed at study entry. The need to target subgroups of cocaine abusers in future pharmacotherapy trials and the possible role of treatment readiness are discussed.

Continuation of high-risk behavior by HIV-positive drug users: Treatment implications

Drug users who are positive for the human immunodeficiency virus (HIV) represent a major vector of HIV transmission, yet relatively little is known about their continued drug- and sex-related HIV-risk behavior, which may impede the development of effective risk-reduction interventions. In this study, 50 HIV-seropositive injection drug users entering methadone maintenance treatment completed a comprehensive risk assessment battery, including self-report of HIV-risk behavior since learning HIV serostatus, and measures of risk-reduction information, motivation, and behavioral skills. We found that a disconcertingly high proportion of patients (66%) reported having engaged in HIV-risk behavior since learning their HIV-seropositive status. Level of HIV-related knowledge did not predict high-risk behavior. Drug-related risk behavior was predicted by psychiatric severity and poor behavioral skills. Sex-related risk was predicted by low levels of motivation and poor behavioral skills. Implications of these findings for treatment are discussed.

Predictors of Nonadherence to HIV-Related Medication Regimens During Methadone Stabilization

Nonadherence to HIV-related medication regimens among drug-abusing patients decreases therapeutic effectiveness and may limit patient access to newer, highly active antiretroviral therapies (HAART). A number of factors have been associated with medication nonadherence; however, few studies have examined predictors of nonadherence specifically in HIV-positive drug abusers. In the current study, a comprehensive assessment battery was administered to 42 HIV-positive, injection drug users beginning methadone maintenance. HIV-related medication adherence was assessed weekly by self-report during the 4-week methadone stabilization phase. Thirty-six percent of patients reported less than 80% adherence to their medication regimen at entry into methadone. Medication adherence increased significantly during the 4-week stabilization phase. Significant zero-order correlations were found between nonadherence during stabilization and viral load, low educational attainment, depression, and neuropsychological tests of problem solving ability and cognitive flexibility. Independent predictors of nonadherence were low levels of education and poor emotional functioning. Implications for early intervention are discussed.

Targeting HIV-related outcomes with intravenous drug users maintained on methadone: A randomized clinical trial of a harm reduction group therapy

Methadone maintenance programs (MMP) have the potential to play an important role in reducing HIV risk, given the appropriate type and level of ancillary treatments. In this study, we investigated the efficacy of a 12-session harm reduction group intervention for injection drug users, based upon the Information-Motivation-Behavioral skills model of behavior change, that focused on reducing both drug and sex risk. Two hundred and twenty patients entering an MMP were randomized to receive either standard care (SC)-2 hours of counseling per month and a single-session risk reduction intervention-or SC plus the harm reduction group (HRG). Results showed that during treatment, patients receiving HRG were more likely to be abstinent from cocaine and to report fewer unsafe sexual practices. Post-treatment, HRG patients scored higher on a sexual risk quiz and reported increased self-efficacy in high risk sexual situations. Enhancing methadone maintenance with a weekly harm reduction group treatment was somewhat more expensive but can bring about positive changes in behaviors and attitudes that are associated with the transmission of HIV.

Spiritual and religious support in recovery from addiction among HIV-positive injection drug users.

Abstract The current study examined the association between support and comfort derived from religion or spirituality and abstinence from illicit drugs in a sample of 43 HIV-positive injection drug users entering a methadone maintenance program. Patients with high ratings of perceived spiritual or religious support were abstinent from illicit drugs significantly longer during the first six months of methadone maintenance than were patients with lower ratings. Controlling for the influence of pretreatment variables (addiction and psychiatric severity, CD4 count, social support, and optimism), and during-treatment variables (methadone dose and attendance at counseling sessions), hierarchical regression analysis showed that strength of religious and spiritual support was a significant independent predictor of abstinence. These findings suggest that spirituality may be an important dimension of patient experience to assess in future addiction treatment outcome research.

Making the shift from ‘addict self ’ to ‘spiritual self ’: Results from a Stage I study of Spiritual Self-Schema (3-S) therapy for the treatment of addiction and HIV risk behavior

A manual-guided intervention, Spiritual Self-Schema (3-S) therapy, for the treatment of addiction and HIV risk behavior is being developed in a Stage I behavioral therapies development project. 3-S therapy integrates a cognitive model of self with a non-sectarian Buddhist framework suitable for people of all faiths. Data are presented on a sample of 29 cocaine- and opioid-dependent clients. Seventy-nine percent completed the 8-week intervention. Drug use and other HIV risk behaviors decreased with treatment. Evidence of a shift in self-schema from ‘addict self ’ to ‘spiritual self ’ is presented. Reaction time to endorse spiritual qualities as ‘me’ and addict qualities as ‘not me’ decreased, and self-report of daily spiritual experiences and practices, and the perceived influence of spirituality on behavior increased. A shift in self-schema was correlated with change in drug use and other HIV risk behaviors.

Acupuncture for the treatment of cocaine addiction investigation of a needle puncture control

We conducted a 6-week, single-blind study of acupuncture for cocaine dependence in methadone-maintained patients (N = 40) for the purpose of identifying an appropriate needle puncture control for use in future large-scale clinical trials. Patients were randomly assigned to receive daily acupuncture in three auricular sites plus one body site (LI-4), or in control sites within 2-3 mm of the four active sites. Overall, there was a positive response to treatment on a variety of drug-related and psychosocial measures. Cocaine use decreased significantly for patients in both needle puncture groups. The only statistically significant difference between the two types of needle puncture was on ratings of craving. Subjects rated each type of needle puncture as equally credible and perceived no significant differences on the acute effects of the two types of needle insertions. Power calculations based on these findings suggest that very large sample sizes would be required to detect treatment differences between this control condition and active acupuncture. Alternative controls are suggested, and the challenges inherent in implementing controlled clinical trials of acupuncture are discussed.

A single-blind investigation of four auricular needle puncture configurations

In order to identify an appropriate needle puncture control for clinical trials of acupuncture we conducted a study in which ten cocaine dependent subjects rated local and systemic effects of four auricular needle puncture configurations (a) sites commonly used for addiction; (b) sites proximate to addiction specific sites; (c) sites not specific for cocaine addiction; and (d) sites in the helix. Subjects received one treatment per day on four successive days. The addiction specific sites were rated highest on local effects; proximal sites a common control were rated highest on systemic effects. A majority of patients ranked the addiction specific sites as the most preferred treatment and the helix points as the least preferred. Results suggest that needle insertion into proximate and non-specific sites may be too active for use as controls; helix regions may be more suitable.

Interpreting Conflicting Findings from Clinical Trials of Auricular Acupuncture for Cocaine Addiction: Does Treatment Context Influence Outcome?

OBJECTIVE To compare findings from two consecutive clinical trials of auricular acupuncture for cocaine addiction conducted at the same site in order to explore consistency of treatment effects. SUBJECTS One hundred and sixty-five (165) cocaine-dependent, methadone-maintained patients (study 1, n = 82; study 2, n = 83). INTERVENTIONS Subjects in both studies were randomly assigned to auricular acupuncture, a needle insertion control condition, or a no-needle relaxation control. Treatment sessions were offered five times weekly for 8 weeks. The two studies were equivalent in design, except that unlike study 1, study 2 offered subject payments for attendance and did not include weekly group counseling. OUTCOME MEASURES Cocaine use assessed by three times weekly urine screens constituted the primary outcome. Secondary measures included retention in treatment, treatment attendance, treatment credibility, therapeutic alliance, and acute effects of treatments. RESULTS Intent-to-treat analysis showed that patients assigned to acupuncture in study 1, but not in study 2, were significantly more likely to provide cocaine-negative urine samples relative to the two control conditions. CONCLUSIONS The positive effect for acupuncture found in study 1 was not found in study 2. Even though the two studies were similar, reasons for this inconsistency cannot be determined definitively, but may be because of differences in psychosocial context and payment contingencies between the two studies, or the lack of effectiveness of acupuncture in this application. The need to critically consider the influence of treatment context and other potential moderating variables on outcome in order to draw conclusions regarding treatment effectiveness is discussed.