View clinical trials related to Cocaine Dependence.
Filter by:The purpose of this pilot treatment trial is to evaluate the efficacy of oral micronized PROG in cocaine-dependent women. Since we have shown (Evans & Foltin, 2006) that oral micronized PROG attenuates the positive subjective effects of smoked cocaine in females, but not in males, and we have preliminary data indicating that oral micronized PROG also reduces smoked cocaine self-administration in the laboratory, PROG appears to be an ideal potential candidate medication to evaluate in cocaine-dependent women. Prior to randomization to treatment, women will reside inpatient for one week to ensure cocaine abstinence since one of the primary outcome measures will be time to cocaine relapse.
This placebo-controlled trial will test the effectiveness of Seroquel XR™ for the treatment of cocaine dependence in non-psychotic individuals who are cocaine dependent.
A 12-week, randomized, double-blind, parallel-group, placebo-controlled trial of citicoline as an add-on therapy will be conducted in 200 outpatients with bipolar I disorder and cocaine dependence. Patients will complete mood and memory assessments weekly, in addition to completing self-report measures for cocaine (and other substances, like alcohol) use and craving. Participants will receive manual-driven Cognitive Behavioral Therapy (CBT: two sessions each week for 4 weeks followed by weekly sessions, total 16 sessions) specifically designed for persons with bipolar 1 disorder and substance abuse, and provided by a therapist with experience in CBT. The sessions may be videotaped for training purposes and may be viewed by the researchers, the therapist, and Dr. Schmitz, a clinical researcher at the University of Texas Houston who is the developer of the CBT for bipolar disorder and substance dependence used in the study. Before being videotaped, the patient will sign an "Authorization for Audio Recordings, Photography, or Other Images for Non-Treatment Purposes" to further understand how the videotape will be used, and by whom. The patient will be given the option to review their videotape to view their therapy session. Once the patient has completed all study procedures, or had discontinued the study, the tape will be destroyed, until then the tape will kept in the patient's confidential study file. Further, patients will return to the clinic three times a week for urine drug tests (UDS). 200 patients are expected to be consented for this study and all study procedures will take place at the clinic on the University of Texas Southwestern Medical Center campus. All non-study medications are not part of the study. Non-study medication will be verbally self-reported by the patient at the time of enrollment into the study. The patient will be responsible for the costs of their non-study related medications. The patient will manage their non-study medications with their personal doctor, including any changes in these medications. However the protocol has concomitant medication algorithm in the event that a change in the medication schedule needs to be made by a study doctor. If a study doctor requests a laboratory test for the patient, it will be paid for by the clinic. Otherwise, the patient will be responsible for all costs (including laboratories) associated with their non-study medications.
The objective of this study is to demonstrate that a larger proportion of vigabatrin-treated subjects than placebo-treated subjects will be cocaine-free in the last 2 weeks of treatment.
The purpose of this study is to address the conditions under which prize contingency management (CM) for abstinence and attendance may improve outcomes of cocaine-dependent patients. For patients who initiate treatment with a cocaine-positive urine specimen, we will evaluate the efficacy of two CM procedures relative to standard, non-CM treatment. The two CM procedures will be provided as additions to standard care and will reinforce drug abstinence but will differ in expected magnitudes of prizes patients can earn, especially during early stages of abstinence. They will provide expected magnitudes of winning about $250 and $560, respectively. We expect that both CM conditions will improve retention and abstinence relative to the standard treatment, non-CM condition. If the enhanced CM condition engenders better outcomes than the $250 CM condition, this finding would suggest that patients initiating treatment while actively using cocaine may best be treated with relatively high reinforcement prize CM as an adjunct to standard care. For patients who initiate treatment with a cocaine-negative urine specimen, we will evaluate the efficacy of a CM procedure that reinforces treatment attendance. The expected magnitude of winnings will be about $250, and again CM treatment will be in addition to standard care. This CM condition will be compared to standard treatment without CM as well as to a CM treatment that provides a similar magnitude of reinforcement, but contingent upon abstinence. Results from this study will inform an important clinical question of whether simply reinforcing attendance can improve clinical outcomes. Increased retention may result in greater exposure to therapeutic processes that may reduce drug use, especially among patients who begin treatment having already achieved some abstinence. We will also evaluate the cost-effectiveness of CM by examining the effects of the interventions on hospitalizations, medical and psychiatric care, criminal justice costs, and productivity.
The proposed investigation will use methadone maintained patients who have concurrent cocaine dependence in order to take advantage of the excellent (over 80%) treatment retention in this patient group and to maximize treatment compliance by daily observed medication with both methadone and levetiracetam. In the initial patients we will explore the tolerability of escalating doses of levetiracetam as well as its potential role in reducing cocaine use, as monitored by self-report and verified by three-times weekly urine toxicology testing in methadone treated patients.The specific aim of this study is to evaluate the tolerability and efficacy of levetiracetam 3 grams/day in modifying cocaine-using behavior, reducing cocaine craving and attenuating cocaine's reinforcing effect among methadone-maintained patients
Cocaine dependence is a chronic, relapsing disorder in which stress/negative mood and exposure to drug-related stimuli or "cues" are associated with high rates of relapse (McKay et al., 1995; O'Brien et al., 1998; R. Sinha, 2001; Shaham et al., 2003). In particular, sex differences in relapse precipitants have been noted, with women reporting greater stress related relapses while men report higher number of relapses associated with drug cue/temptation situations (Lex, 1991; McKay et al., 1996; R. Sinha, 2001; R. Sinha, Rounsaville BJ, 2002). Current SCOR studies have shown that stress and cocaine cues increase drug craving and stress related arousal, responses that differ in cocaine men and women (R. Sinha et al., 2003; H.C. Fox et al., 2005a). Furthermore, stress-induced cocaine craving and HPA responses are predictive of cocaine relapse, which is also moderated by gender (R. Sinha et al., 2006). However, no previous research has examined the basis of sex differences in stress and cue induced craving and arousal, both of which are known to increase relapse susceptibility. Greater knowledge of the sex-specific neurobiology of cocaine dependence will facilitate development of gender-specific cocaine relapse prevention efforts. Growing evidence supports a role for gonadal hormones in explaining the sex differences observed in stress responses as well as in the behavioral responses to cocaine (Festa & Quinones-Jenab, 2004; K. Carroll, Fenton LR, Ball SA, Nich C, Frankforter TL, Shi J, Rounsaville BJ, 2004; Lynch, 2006; Kajanti & Phillips, 2006). Estrogen increases behavioral responses to cocaine, while presence of progesterone decreases subjective and behavioral effects of cocaine, more so in females than males (Jackson et al., 2006; Sofuogu et al., 1999; M. Sofuoglu et al., 2002; Evans & Foltin, 2006). Stress and cocaine each enhance brain stress circuits, namely the corticotrophin releasing factor (CRF)-hypothalamic-pituitary-adrenal (HPA) axis and central noradrenergic/sympatho-adrenomedullary (SAM) pathways and both activate the mesolimbic dopaminergic systems involved in the rewarding effects of cocaine (ADD REFS). Exposure to Stress, cocaine or cocaine cues will each increase cocaine craving and HPA axis responses. Importantly, progesterone which affects behavioral responses to cocaine, also plays a key role in stress regulation. However, it is not known whether progesterone alters stress-induced and drug cue-induced craving and related stress arousal, markers that predict cocaine relapse outcomes. Our preliminary data suggest that women exposed to stress and to drug cues in the laboratory during the luteal phase (high progesterone) show lower stress induced and drug cue-induced craving, anxiety and cortisol responses compared to those in the late follicular phase (high estrogen) (see preliminary Studies section CX). On the basis of this previous research, we propose a double-blind placebo controlled study of to examine progesterone's effects on stress and cue-related responses in cocaine dependent men and women. We hypothesize that high dose of progesterone (200 mg bid) vs. placebo will alter stress-induced cocaine craving, negative affect, physiological and HPA responses to stress, and these changes will be greater in women than men.
Subjects participating in this protocol will participate in three phases: 1) pre-admission, 2) inpatient admission, and 3) follow-up. Pre-admission involves screening (detailed in inclusion/exclusion criteria section) and one week of outpatient sleep and activity monitoring. Inpatient admission is 16 consecutive nights on the Clinical Neuroscience Research Unit and involves subjective and objective tests of sleep, sleepiness, attention, and learning. During inpatient admission subjects will take modafinil or placebo. For follow-up, subjects will return to the CNRU for one night and again participate in objective tests of sleep, sleepiness, attention, and learning. We hypothesize that modafinil will decrease subject and objective measures of sleepiness and will promote attention and learning in cocaine dependent persons.
Concurrent dependence on cocaine occurs in up to 50% of the over one million opiate dependent patients in spite of methadone maintenance treatment being highly effective for opiate dependence and having excellent treatment retention. Cocaine dependence has remained largely unresponsive to medications both in and outside of these methadone programs. We have initial data from our open-label study with levetiracetam showing that this medication is well tolerated and may reduce cocaine use in this cocaine-abusing methadone treated population. The specific aim of this study is to evaluate the efficacy of levetiracetam 3 grams/day in modifying cocaine-using behavior, reducing cocaine craving and attenuating cocaine's reinforcing effect among methadone-maintained patients. The primary outcomes will be reduction in cocaine use as assessed by self-report and thrice-weekly urinalyses. Secondary outcomes will include weeks in treatment (retention) and change in measures of cocaine craving, anxiety symptoms and opiate withdrawal symptoms.
Subjects will be randomly assigned to receive either one of the two potential dose combinations of the study medications or placebo over 6 weeks. The study will include twice weekly visits to the research clinic for laboratory studies, safety assessments and urine drug screens. Subjects will also be questioned regarding drug craving and mood symptoms.