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Opioid-Related Disorders clinical trials

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NCT ID: NCT01728909 Completed - Substance Abuse Clinical Trials

Methadone Oxytocin Option

MOO
Start date: May 2012
Phase: Early Phase 1
Study type: Interventional

The purpose of the study is to examine the effects of intranasal oxytocin administration on social cognition in patients receiving methadone maintenance treatment (MMT), examine the effects of intranasal oxytocin administration on opioid craving and on the subjective effects of methadone, and examine the effects of intranasal oxytocin administration on implicit preferences for drug-related and social stimuli in patients receiving MMT. Hypothesis 1: Patients will perform better on measures of social cognition (including affect recognition and recognition of sarcasm) after administration of oxytocin compared with placebo. Hypothesis 2: Patients will demonstrate lower craving for opioids and greater subjective effects of methadone after administration of oxytocin compared with placebo. Hypothesis 3: Patients will demonstrate increased implicit preferences for social stimuli and decreased implicit preferences for drug related stimuli after administration of oxytocin compared with placebo.

NCT ID: NCT01722435 Completed - Opioid Dependence Clinical Trials

Completion of OST - a Prospective Study

Start date: July 2011
Phase:
Study type: Observational

Only limited information on the process of completing long-term opiate substitution treatment (OST) with substances like methadone exist. Furthermore, systematic knowledge from scientific studies is scarce, there are only few studies with respect to treatment completion or regular termination (mainly catamnestic analyses). Studies by Nordt et al. (2004) or Nordt & Stohler (2006) show an estimated rate of 10% of patients per year who terminate OST by means of tapering the substitution agent or changing into withdrawal treatment in specialized clinics. It is state of the art that an indication for termination of OST has to be based on a common agreement between the patient and the doctor. Furthermore, the patient should live in a stable social situation and the state of health had markedly improved. Finally, the patient has to be free of (illegal) drug use for at least 6 months and the individual aims of treatment should have been reached (Vader et al. 2003). The main objective of the prospective and explorative study is the systematic description of the process of termination of OST. With a comparison between patients who complete OST regularly and patients who terminate treatment prematurely (or are still in treatment) predictors of positive termination of OST can be identified. Patients treated with methadone or levomethadone of 5 general practitioners' practices and 2 specialized clinics who might be able to terminate OST during the next 12 months from the doctors' perspective can take part in the study. In addition to baseline examination further assessments take place every 3 months (i.e. after 3, 6, 9 and 12 months). The questionnaires include state of health, well-being, social situation as well as drug and alcohol use. Furthermore, the treating doctors are asked every 3 months to fill out questionnaires on infections and other disorders, clinical characteristics, dosage process and drug use (measured by urine samples). Patients who will be successful in completing OST during the observational period will be compared with the remaining cases. Finally, a 6-month follow-up is planned in order to investigate the stability and maintenance of the situation at month 12.

NCT ID: NCT01718964 Completed - Opioid Dependence Clinical Trials

Acute Effects of Cortisol on Heroin Craving in Opioid Dependence (Ghost-Basel)

Ghost-Basel
Start date: November 2012
Phase: Phase 2
Study type: Interventional

To investigate the effects of cortisol on heroin craving and stress reaction in heroin addicted subjects Randomized, double-blind, placebo-controlled, cross-over, single administration of study medication Study hypothesis:Cortisol has an inhibiting effect on heroin craving and stress reactivity in opioid dependent subjects.

NCT ID: NCT01717963 Completed - Opioid Dependence Clinical Trials

Naltrexone vs Buprenorphine-Naloxone for Opioid Dependence in Norway

NTX-SBX
Start date: October 2012
Phase: Phase 3
Study type: Interventional

Persons dependent on opioids like heroin, morphine, or codeine have a high risk of relapse, overdose and overdose death. This risk is elevated even further following discharge from treatment or correctional institutions where patients have been detoxified. At the moment, state-of-the-art treatment is based on maintaining the dependence on opioids by daily intake of opioid medications like methadone or buprenorphine. Recently, a medication containing the blocking agent naltrexone was approved in the US; this does not maintain dependence but instead blocks heroin and other opioids for 28 days after intramuscular administration. This study will conduct a 12-week randomized comparison of naltrexone intramuscular suspension (XL-NTX) with daily buprenorphine-naloxone in OMT. Medication will start preceding discharge from a treatment or correctional facility to participating catchment regions in Norway. The main hypotheses are that XL-NTX will do equally well as - or better than - OMT on the proportion of biological samples negative for opioids, retention, self-reported use of alcohol and illicit drugs. Following the 12-week randomized period, there will be a 36-week period where participants can receive the study medication of their choice. After the end of the study, data from national registry databases can be collected for a further 12 months on outcomes such as recidivism, mortality and morbidity.

NCT ID: NCT01666119 Completed - Opioid Dependence Clinical Trials

An Open Label Study To Assess The Safety And Tolerability Of BEMA® Buprenorphine NX In Opioid Dependent Subjects

Start date: August 2012
Phase: Phase 2
Study type: Interventional

This is an open label study in opioid dependent subjects maintained on a stabilized dose of Suboxone tablets or films. The purpose is to assess the safety and tolerability of BEMA Buprenorphine NX administered once daily for 12 weeks to opioid dependent subjects stabilized on Suboxone (buprenorphine/naloxone) tablets or films. Eligible subjects will be converted to an approximately equal dose of BEMA Buprenorphine NX. This dose will be taken throughout the 12-week treatment period with dose adjustments as clinically indicated for either the control of opioid dependence or adverse events (AEs).

NCT ID: NCT01605539 Completed - Opiate Addiction Clinical Trials

Acute and Short-term Effects of Cannabidiol Admin on Cue-induced Craving in Drug-abstinent Heroin Dependent Humans

Start date: May 2012
Phase: Phase 2
Study type: Interventional

Despite the current available therapies for opioid-dependent patients, most patients relapse. This research project focuses on the development of a novel compound, cannabidiol, to modulate opioid craving in humans based on animal models showing its selective effectiveness to inhibit drug-seeking behavior. The development of a targeted treatment for opioid relapse would be of tremendous medical and public health value.

NCT ID: NCT01595867 Completed - Chronic Pain Clinical Trials

Abuse Potential Assessment of Intranasally Administered EMBEDA Compared To Morphine Sulfate Controlled Release And Placebo

Start date: August 2010
Phase: Phase 1
Study type: Interventional

This was a single-dose, randomized, double-blind, placebo-controlled, 3 way crossover study designed to evaluate the relative abuse potential of crushed EMBEDA® compared to morphine sulfate CR tablets and placebo in healthy male and female, non-dependent, recreational opioid users. An appropriate dose of morphine sulfate CR (i.e., 30 mg, 60 or 90 mg) was to be selected during Part A of the study (Dose Selection Phase). Each subject participated in the study for up to (approximately) 16 weeks and was confined in the clinic for a total of up to 12 nights.

NCT ID: NCT01592461 Completed - Opioid Dependence Clinical Trials

Starting Treatment With Agonist Replacement Therapies Follow-up Study

Start date: September 2010
Phase: N/A
Study type: Observational

The purpose of the study is to conduct a follow-up of substance abuse patients (n=1,269) about 2 to 5 years since they were originally recruited from 8 substance abuse treatment clinics (located in 5 states) to participate in a prior clinical trial study called "START" (Starting Treatment with Agonist Replacement Therapies). The START Follow-up Study will be conducted over 5 years and will involve three follow-up interviews with START participants. The specific aims of the START Follow-up Study are as follows. 1. To determine longer-term outcomes of Suboxone versus methadone treatment received in the START 2. To investigate patient and treatment factors associated with post-START treatment access, utilization, and outcomes among Suboxone and methadone patients 3. To explore other correlates of the long-term outcomes among START patients.

NCT ID: NCT01582347 Completed - Clinical trials for Opioid Related Disorder

Transfer of Subjects From Subutex/Suboxone to RBP-6300

Start date: March 2012
Phase: Phase 2
Study type: Interventional

This study is designed to determine if opioid dependent subjects who are already receiving Subutex and/or Suboxone can transfer to RBP-6300. Upon completing the study, subjects will continue their pre-study prescribed dosage of Subutex and/or Suboxone

NCT ID: NCT01570699 Completed - Clinical trials for Opioid-related Disorders

Variation of COMT Val158Met Polymorphism Between COM-ON Patients and METHADOSE Patients

COM-ON
Start date: December 2012
Phase: N/A
Study type: Observational

The main objective is to compare the genotypes of the COMT Val158Met polymorphism between opiate-users and opiate-dependent subjects. The secondary objective is to constitute a sample of opiate-users without any lifetime opiate dependence.