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Heroin Dependence clinical trials

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NCT ID: NCT01999946 Completed - Clinical trials for Opioid-Related Disorders

Extended-Release Naltrexone Opioid Treatment at Jail Re-Entry

XOR
Start date: June 27, 2014
Phase: Phase 4
Study type: Interventional

The purpose of this study is to compare the effectiveness of extended-release naltrexone (XR-NTX) vs. enhanced treatment-as-usual (TAU) among opioid dependent adults leaving NYC jails. In parallel, we propose to recruit a matched, quasi-experimental methadone cohort, which will result in a naturalistic comparison of XR-NTX vs. an established jail-based methadone treatment program standard-of-care. Our primary aim is to compare time-to-relapse among participants treated with XR-NTX vs. randomized TAU controls and time-to-relapse among XR-NTX arm vs. jail-based MTP participants, following release from jail. Secondary aims will compare related opioid treatment outcomes post-release across all arms.

NCT ID: NCT01760473 Completed - Heroin Dependence Clinical Trials

Reinforcing Effects of Intranasal (IN) Buprenorphine Versus Buprenorphine/Naloxone

Start date: May 2009
Phase: Phase 3
Study type: Interventional

The study is designed to compare the abuse liabilities of intranasal buprenorphine and buprenorphine/naloxone in individuals who are physically dependent on sublingual buprenorphine. The investigators hypothesize that the abuse liability of buprenorphine/naloxone is lower than that of buprenorphine alone.

NCT ID: NCT01723527 Completed - HIV Clinical Trials

Diversion to Treatment for Injection Drug Users Arrested for Possession of Heroin

Start date: December 2012
Phase: Phase 1
Study type: Interventional

More Americans are arrested for drug offenses than for any other crime. In 2009, over 294,000 arrests were made for possession of cocaine or heroin. Incarceration does not address the root problems and is frequently followed by relapse and re-arrest after release. In the case of opiate-dependent adults arrested for possession of heroin, one potentially effective alternative is to divert offenders to methadone maintenance treatment (MMT) as an alternative to adjudication of their case. MMT is an effective treatment for heroin dependence, and appears very effective for criminal offenders. However, cocaine use is common in MMT patients, including those with recent criminal justice involvement, and MMT alone is ineffective in addressing cocaine use. Continued cocaine use carries a substantial health burden and necessarily entails continued criminal activity. Thus, treatment for diverted opiate-dependent offenders should be designed to address cocaine use as well as opiate use. A Stage 1 Behavior Therapy Development project is planned over 2 years to adapt, manualize and pilot test the Therapeutic Workplace intervention for adults charged with heroin possession and offered diversion to methadone maintenance treatment as an alternative to adjudication of their case. The Therapeutic Workplace is a novel, employment-based contingency management intervention that has been very effective in promoting cocaine abstinence in adults who use cocaine persistently during methadone treatment. In the Therapeutic Workplace, participants are hired in a model workplace and required to provide drug-free urine samples to work and to earn maximum pay. Once we develop and manualize the adapted version of the Therapeutic Workplace for adults arrested for heroin possession, a pilot test will be conducted. Individuals identified by the State Attorney's office as candidates for diversion will be assessed for study eligibility. Given the high rates of injection drug use and injection-related transmission of HIV in Baltimore, this study will be restricted to injection drug users to evaluate the potential utility of this intervention in reducing HIV risk. Eligible individuals will be offered methadone maintenance in lieu of prosecution and will be required to remain in methadone treatment for 90 days. All participants will receive standard MMT, independent of whether they decide to participate in the pilot study. After beginning MMT, participants will be invited to enroll in the pilot study and randomly assigned to two study groups. Participants assigned to the Usual Care Diversion group will receive the standard MMT. Participants assigned to the Therapeutic Workplace Enhanced Diversion group will receive the standard MMT and the Therapeutic Workplace intervention. The data from this pilot study will serve as the foundation for a full-scaled randomized controlled trial. Overall, the Therapeutic Workplace could serve as a novel and ideal intervention for many heroin dependent adults involved in the criminal justice system. The use of MMT in lieu of adjudication in combination with the Therapeutic Workplace could increase drug abstinence and employment and decrease HIV risk and criminal activity in this refractory high-risk population.

NCT ID: NCT01668706 Completed - Heroin Dependence Clinical Trials

Pharmacogenomics Study of Sleep Disturbance and Neurocognitive Impairments in the Opioid Addicts

Start date: March 2009
Phase: N/A
Study type: Observational

Opioid abuse is a complex problem, which not only impacts on addicts' physical and psychological health individually, but also threats the society. Recently, spread of HIV via sexual behavior and needle sharing among injecting drug users (IDUs) also becomes a serious public health problem all over the world. In Taiwan, since the first HIV-infected IDU identified in 1987, the incident cases have mounted to 2,461 in 2005. To prevent the epidemics of HIV among IDUs, the Center for Disease Control (CDC) thus collaborated with Department of Justice and implemented harm reduction programs in 2005. It is the milestone that opioid addiction is officially treated as a health rather than a legal issue in Taiwan. Among the harm reduction programs of needle and syringe exchange for IDUs as well as substitution treatment for opioid dependence, methadone maintenance treatment (MMT) is one of the most important parts. Till 2008, there were over 13,000 heroin addicts participated in more than 80 MMT programs. Although the clinical evidences have proven the superior effectiveness of maintenance therapy in ameliorating illicit substances abuse, decreasing criminality and improving quality of life, there are common problems of sleep disturbance and neurocognitive impairments among the subjects receiving opioid medications. The concerns of the adverse effects might thus frustrate the subjects' motivation and compliance to maintain treatments. However, sleep disturbance and neurocognitive impairments related to opioid medications are often neglected in the clinical practices and there are scanty researches focusing on these crucial issues in the existing literature. In this prospective study, four groups of subjects including methadone maintenance treatment, buprenorphine/naloxone, medication-free opioid ex-addicts and healthy volunteers will be enrolled. Via the comprehensive assessments including clinical interview, neurocognitive examinations, electrocardiogram-based sleep breathing detector and pharmacogenomical evaluation, we will not only have the opportunities to have more insights on the impacts of opioid medications on sleep and neurocognitive performances, but also develop more adequate strategies to improve motivation and outcome in treating the opioid addicts.

NCT ID: NCT01580163 Completed - Heroin Addiction Clinical Trials

Efficacy Evaluation of Traditional Chinese Medicine JITAI Combined Comprehensive Model Among Heroin Addicts After Detoxification

Start date: September 2009
Phase: N/A
Study type: Interventional

The purpose of this research is to observe the efficacy of comprehensive treatment model to improve treatment compliance and relapse prevention.

NCT ID: NCT01536925 Completed - Clinical trials for Opioid-Related Disorders

Studies of Opioid Seeking Behavior: Yohimbine and Hydrocortisone Effects

YHO
Start date: December 2011
Phase:
Study type: Observational

This research deals with behaviors that are part of opioid dependence. The purpose is to study the extent to which stress and other factors, including money and amount of work effort, affect opioid choice. Specifically, the investigators will examine the effects of three issues/factors. The first is how hard participants are willing to work to obtain an opioid drug; the second is how much opioid drug would participants choose instead of money; and the third factor is how much participant's opioid drug choices are influenced after they are administered the drugs yohimbine and hydrocortisone, both of which could produce stress-like symptoms.

NCT ID: NCT01527994 Completed - Opioid Dependence Clinical Trials

Aprepitant Effects in Intravenous Heroin Dependence

Start date: January 2012
Phase: Phase 1
Study type: Interventional

Current treatments for opioid addiction would benefit by the addition of a non-opioid based treatment medication. Recent behavioral studies have shown that the neurokinin-1 (NK1) receptor is involved in opioid reward and withdrawal. This study proposes to study a potential non-opioid treatment, the clinically available, FDA approved, NK1 antagonist aprepitant, in opioid addicted patients. Based on the unique behavioral and pharmacological characteristics of opioid addiction, and what is known of the currently employed treatments, the investigators propose that the therapeutic mechanism of any potential opioid addiction treatment medication must include the ability to reduce opioid withdrawal. This is of particular importance during treatment initiation (eg. detoxification). In addition, for long-term treatment and relapse prevention, it is important to manage drug craving and inhibit the rewarding effects of opioids if patients do experience a slip. Therefore, the investigators propose to study aprepitant using human models of opioid withdrawal, craving and acute opioid reward and reinforcement. The investigators will also include a neuro-economics choice procedure paradigm.

NCT ID: NCT01471145 Completed - Clinical trials for Opioid-Related Disorders

Depot Naltrexone Mechanism of Action in Heroin Dependent Patients Using fMRI and SPECT

XRNT
Start date: January 2013
Phase: Phase 4
Study type: Interventional

The aim of this project is to study brain functions of 20 heroin addicts (compared to brain functions of 20 healthy controls) just before and during a three month extended release naltrexone treatment using functional MRI and dopamine transporter SPECT. The following hypotheses are tested: - XRNT modulates the fMRI response to drug cues in predetermined brain regions. - The expression of striatal transporters (assessed with SPECT) will decrease after a three-month course of extended release naltrexone

NCT ID: NCT01457872 Completed - Clinical trials for Substance Use Disorders

Malmö Treatment Referral and Intervention Study

MATRIS
Start date: October 2011
Phase: N/A
Study type: Interventional

This study aims to study and implement active referral of heroin users from a syringe exchange programme to evidence-based treatment for heroin addiction. Patients are randomized to either a strength-based case management intervention or a control group, while both groups receive referral to medical investigation for inclusion in substitution treatment for heroin addiction. The hypothesis is that syringe exchange can be used for referral to effective treatment, and that a strength-based intervention can increase the number of patients who are successfully referred and enter treatment.

NCT ID: NCT01447212 Completed - Opioid Dependence Clinical Trials

Study to Assess Longer-term Opioid Medication Effectiveness (SALOME)

SALOME
Start date: December 2011
Phase: Phase 3
Study type: Interventional

The purpose of this study, SALOME, is to determine if 1) the closely supervised provision of injectable, hydromorphone (HDM; trade name Dilaudid™) is as effective as injectable diacetylmorphine (DAM; heroin) in the treatment of chronic, multi-morbid opioid-dependent individuals who have not benefited sufficiently from conventional treatments, and if a switch to the oral equivalent of hydromorphone and diacetylmorphine is as effective as the injection form. The availability of an effective, licensed opioid medication such as hydromorphone, for substitution treatment of chronic, multi-morbid treatment-refractory opioid-dependent individuals, would be of immense impact locally and internationally. It could help to establish alternative treatment options where for non-medical reasons Heroin Assisted Treatment would not be acceptable. Thus, one result could be the expansion of treatment options for the most difficult to treat heroin dependent persons. This would also be an important step for secondary prevention of HIV and Hepatitis C as well as a better integration of those patients in other medical treatments. Switching from intravenous to oral application would also reduce a lot of potential risk factors (like overdose, seizures, infections, etc) and side effects associated with the injection route. Additionally it could make these treatments more feasible in normal treatment settings, like existing methadone services.