National Institute on Drug Abuse (NIDA)

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A Study of the Relationship Between Disulfiram and Cocaine Self-Administration.

Trial phase: 
Phase I
Recruitment status: 
Suspended

The problem of cocaine dependence remains a major medical, social, and legal concern. Several studies have suggested that disulfiram may be beneficial for the treatment of cocaine dependence. A common assumption has been that disulfiram treatment, by increasing DA availability, enhances the aversive aspects of stimulants. This study aims to measure plasma activity in those with the C/C DBH genotype, which is associated with higher DBH activity subsequently making the disulfiram treatment more effective, as well as determine the effects of treatment with disulfiram on cocaine self-administration using a human laboratory model of cocaine self-administration.

Background information
Trial ID: 
NCT00729300
Other unique IDs: 
05-08-071-02A
Official title: 

Laboratory Models of Cocaine Self-Administration

Detailed description: 

 

Number to be enrolled: 
60 patients

Chronic Pain and Opioid Dependence Assessment and Treatment

This study involves the development of an integrated psychotherapy that addresses both chronic pain and opioid dependence(POD).

Background information
Other unique IDs: 
1K23DA024050-01A1

Phase IIa Study of AV411, a Glial Activation Inhibitor, for Opioid Withdrawal

Repeated use and/or abuse of opioid medications is generally associated with a characteristic withdrawal syndrome that develops after cessation of drug administration. Opioid-induced cytokine release and glial activation has been proposed to directly contribute to the affective and physiological aspects of withdrawal. Furthermore, cytokine release following opioid administration has been hypothesized to be a limiting factor in both the duration and magnitude of opioid-induced analgesia. The two primary goals of our study are to assess AV411's ability to 1) reduce the opioid-withdrawal syndrome and 2) increase and prolong the analgesic effects of the mu-opioid agonist, oxycodone. To explore whether AV411 decreases opioid-induced glial cell activation, some participants assigned to the placebo and high dose AV411 groups (n = 6 for each dose condition) will be studied twice with [11C]PK11195, a positron emission tomography (PET) radiotracer used to measure the peripheral benzodiazepine receptor (PBR) in the human brain. The PBR is a receptor located on the mitochondria of the microglia and can be used to examine microglial activation in various brain regions.

Background information
Other unique IDs: 
IRB#5725
DA09236

Woman-Focused HIV Prevention With Pregnant African-Americans

We will iteratively adapt and modify the NC woman-focused intervention (Women's CoOp), including the field manual and instrumentation, to focus on pregnant African-American women who abuse crack, are currently in substance abuse treatment, and are at risk for HIV or are HIV positive. We then will test the newly developed intervention in a Stage IB pilot-sized randomized clinical trial (RCT) in a traditional substance abuse treatment clinic to determine (a) feasibility; (b) relative efficacy compared with substance abuse treatment-as-usual (TAU), across several domains of functioning (e.g., substance use, HIV risk behaviors); and (c) the intervention's potential mechanisms of action. The specific aims of this Stage IA/B study are as follows: Aim 1. To adapt the culturally specific, manualized woman-focused intervention to specifically address issues of pregnancy and substance abuse, relationships with men, social support, parenting, HIV status, living with HIV, antiretroviral (ARV) treatment, and HIV risk-reduction methods for pregnant and postpartum women. Aim 2. To compare the relative efficacy of the woman-focused intervention for pregnant women relative to standard substance abuse treatment to sustain reductions in substance abuse and sexual risk behaviors, maintain retention in drug treatment, reduce violence, and improve prenatal care and ARV treatment adherence (as needed) at 3- and 6-month follow-up. Aim 3. To explore the intervention's potential mechanisms of action (e.g., by examining the mediating effects of changes in knowledge about HIV risk behaviors, psychological distress, readiness for change) and moderating factors (e.g., HIV status, age, stage of pregnancy, relationships with men) that may influence response to the treatment.

Background information
Other unique IDs: 
R01 DA020852

Cognitive Behavioral Stress Management for HIV+ Drug Abusers

Trial phase: 
Phase I
Recruitment status: 
Completed

The primary purpose of this 5-year study is to determine whether a Cognitive Behavioral Stress Management (CBSM) intervention, demonstrated to be effective in reducing distress, enhancing coping, and maintaining health among HIV+ non-drug abusers (see Schneiderman and Antoni, 2000), can be effectively adapted for our target population of culturally diverse, HIV+, low-income "Recovering Drug Abusers" (RDAs). Since the late 1980s, members of our research team (i.e., Schneiderman, Antoni, Klimas, Fletcher) have been developing, refining and evaluating the effects of CBSM among HIV+ Men who have Sex with Men (MSM). In the early/mid 90s, we began to adapt and evaluate the effects of CBSM in other non-drug abusing subgroups that were emerging with increasing levels of HIV seroprevalence (e.g., pregnant women, African American and Hispanic men and women). After accumulating considerable support for the effectiveness of CBSM in these subgroups in the late 90s, our research team (i.e., Malow, Schneiderman, Antoni, Klimas, Page) turned its attention to developing the CBSM for one of the most neglected and understudied populations affected by the HIV/AIDS epidemic in this country: "inner city" minority drug abusers. With supplemental funding on two NIH grants to conduct formative stage1 pilot research, our project team has been able to develop and document the feasibility and potential promise of the CBSM approach adapted/translated for RDAs (CBSM-RDA). This application proposes to take the next logical step in continuing this work: conducting a 3, 6, 8, 10, and 12 month follow-up outcome study comparing CBSM-RDA with a matched attention, time and interest value Health Promotion Comparison (HPC) condition, in 225 male and 225 female HIV+ RDAs with respect to key biopsychosocial health endpoints: distress (i.e., depressive symptoms, and mood state), quality of life, drug abuse relapse, unsafe sex, Combination Antiretroviral Therapy (CART) medication adherence and health status indicators (e.g., Viral Load, CD4 count, physical symptoms).

Background information
Trial ID: 
NCT00722644
Other unique IDs: 
DA13802
Official title: 

Cognitive Behavioral Treatment of HIV+ Drug Abusers

Detailed description: 

The primary purpose of this proposed 5-year study is to determine whether a Cognitive Behavioral Stress Management (CBSM) intervention, demonstrated to be effective in reducing distress, enhancing coping, and maintaining health among HIV+ non-drug abusers (see Schneiderman and Antoni, 2000), can be effectively adapted for our target population of culturally diverse, HIV+, low-income "Recovering Drug Abusers" (RDAs).

Number to be enrolled: 
450 patients

Effective Treatment for Prescription Opioid Abuse

Trial phase: 
Phase II
Recruitment status: 
Recruiting

There has been an alarming increase in abuse of prescription opioids in recent years. This project aims to develop an effective outpatient treatment for prescription opioid (PO) abuse that combines an intensive behavioral therapy with a pharmacotherapy regimen of buprenorphine detoxification and naltrexone maintenance.

Background information
Trial ID: 
NCT00719095
Other unique IDs: 
R01-DA019989
Official title: 

Effective Treatment for Prescription Opioid Abuse

Detailed description: 

There has been an alarming increase in abuse of prescription opioids in recent years. This project aims to develop an effective outpatient treatment for prescription opioid (PO) abuse that combines an intensive behavioral therapy with a pharmacotherapy regimen of buprenorphine detoxification and naltrexone maintenance. Aim 1) Conduct a randomized, three-parallel-groups clinical trial (Study 1) to determine a buprenorphine dose-tapering schedule that prevents the poor retention and relapse that undermine many opioid detoxification regimens.

Number to be enrolled: 
210 patients

Incentive-Based Smoking Cessation for Methadone Patients

Trial phase: 
Phase II
Recruitment status: 
Recruiting

The prevalence of cigarette smoking among patients receiving opioid agonist treatment, such as methadone or buprenorphine maintenance, is more than three-fold that of the general population and is associated with increased morbidity and mortality. The overarching goal of this project is to systematically develop a voucher-based contingency-management (CM) intervention for promoting initial and longer-term abstinence from cigarette smoking in patients receiving methadone or buprenorphine treatment for their opioid abuse.

Background information
Trial ID: 
NCT00718835
Other unique IDs: 
R01-DA019550
Official title: 

Incentive-Based Smoking Cessation for Methadone Patients

Detailed description: 

The prevalence of cigarette smoking among patients receiving opioid agonist treatment, such as methadone or buprenorphine maintenance, is more than three-fold that of the general population and is associated with increased morbidity and mortality. Despite these statistics, little is known about how to effectively help opioid-maintained patients to quit smoking. We believe a treatment that successfully promotes smoking cessation in these patients would offer exciting potential for dissemination.

Number to be enrolled: 
170 patients

Healthy Activities for Prize Incentives

In this Stage 1 therapy development project, we plan to develop, formalize, and derive effect size estimates of a contingency management (CM) therapy that focuses on improving health, especially as related to increasing low intensity physical activities, such as walking, resistance training, and stretching. The Healthy Activities for Prize Incentives (HAPI) intervention will be targeted toward and tested within HIV-positive substance abusers who attend HIV drop-in centers. After initial therapy development in a Stage 1a pilot project with 9 patients, the therapy manuals and materials will be adapted and refined. In a Stage 1b controlled trial, we will recruit and randomize 50 substance abusing HIV-positive patients to (a) HAPI plus 12-step facilitation therapy or (b) contingency management for abstinence plus 12-step facilitation therapy. Each intervention will consist of one weekly individual therapy session for 16 weeks. All participants will provide urine and breath specimens twice weekly that will be tested for opioids, cocaine, methamphetamine, marijuana and alcohol. Patients in both conditions will earn the chance to win prizes for submitting drug-negative specimens, and those randomized to the HAPI condition will also earn the chance to win prizes for engaging in healthy activities. Physical activity levels, drug use, psychological symptoms, and subjective and objective indicators of health (body mass index, waist circumference, blood pressure, viral load) will be measured pre-treatment and at months 2 and 4 (post-treatment), as well as at a 7-month (3 months after treatment) follow-up evaluation. Compared to those receiving 12-step facilitation with contingency management for abstinence, we expect that those in the HAPI condition will participate in more physical activities, decrease drug use to a greater extent, evidence reduced depression, and show trends toward improvements in health indices. If effect sizes in at least the small to medium range are noted across all domains, we will consider the therapy appropriate for further evaluation in a Stage 2 therapy development study.

Background information
Other unique IDs: 
08-251-2
1R01DA022739-01A2

Interventions for Smoking Among Persons in Recovery

Recruitment status: 
Active, not recruiting

Examine the efficacy of a stepped-care smoking cessation intervention for current and former smokers in chemical dependency treatment programs. We hypothesize that those who received the stepped-care intervention will be more likely to report smoking abstinence and drug or alcohol abstinence at 6 months.

Background information
Trial ID: 
NCT00714896
Other unique IDs: 
P50DA009253-14-DevStudy2
H10315-28247-03
P50DA009253-14
Official title: 

A Stepped-Care Intervention for Current and Former Smokers in Outpatient Chemical Dependency Treatment

Detailed description: 

The objective of the study is to document and systematically investigate the use of smoking cessation strategies targeting substance abuse outpatient smokers at various level of readiness to quit smoking. Little is known regarding the best practices in treating tobacco use among clients in drug abuse treatment and very few drug abuse treatment programs currently offer smoking cessation services.

Number to be enrolled: 
75 patients
Acronym: 
INSPIRE

Treating Chinese Smokers With Interactive Expert System

Recruitment status: 
Completed

The research study examined the feasibility, implementation, and efficacy of the interactive expert system intervention for smoking cessation in the Chinese American population.

Background information
Trial ID: 
NCT00713895
Other unique IDs: 
5K23DA000468
Official title: 

Treating Chinese Smokers With Interactive Expert System

Detailed description: 

The research study examines the feasibility, implementation, and efficacy of the interactive expert system intervention for smoking cessation in the Chinese American population. The primary specific aim of the proposed research is to test the following hypotheses: 1) Proactive recruitment approach will be more effective in recruiting smokers who are in precontemplation (no intent to quit smoking in the next 6 months) than a reactive approach.

Number to be enrolled: 
363 patients
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