Treatment Trials

28 Clinical Trials for Various Conditions

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COMPLETED
Development of a Videogame Prototype Targeting Cigarette and Marijuana Smoking, and Tobacco Product Prevention Among Young Adolescents (smokeScreen)
Description

The goal of this sub-study is to learn more about how an educational videogame can feasibly be implemented and disseminated in youth programs.

Conditions
COMPLETED
Development of a Videogame Prototype Targeting Cigarette and Marijuana Smoking, and Tobacco Product Prevention Among Young Adolescents
Description

To study feasibility and implementation of a education videogame and the effects on adolescents knowledge and beliefs around tobacco products.

Conditions
COMPLETED
Behavioral Economic Analysis of Demand for Marijuana
Description

This laboratory study will employ a multi-session experimental design to examine the behavioral economic demand for marijuana, by studying effect of marijuana administration (High THC) on demand for marijuana, and marijuana smoking topography. The study will recruit 100 non-treatment seeking marijuana users who smoke marijuana at least twice weekly.

COMPLETED
An Exercise App to Reduce Young Adults' MJ Use
Description

Currently, marijuana (MJ) is the most popular illicit drug, but there are few effective interventions to help young adults (age 18 to 25 years) to reduce their MJ intake. In this study, we will develop and initially test a smart phone app designed to promote exercise/physical activity as a positive alternative to MJ use. The app will be tested in an efficacy study in which MJ users are randomly to either receive personalized feedback about MJ use + use the exercise app or personalized feedback only. The results will contribute to knowledge about exercise/physical activity as a strategy for reducing young adults' MJ use and problems.

COMPLETED
Effects of Dronabinol (Oral THC) on Cannabis Use
Description

Study participants received dronabinol (0, 120mg/day and 240mg/day) for 12 consecutive days in a randomized order. During each dronabinol maintenance period they were able to self-administer active or placebo cannabis using either a progressive ratio schedule or choice between cannabis and monetary alternative.

COMPLETED
Effect of Quetiapine on Marijuana Withdrawal and Relapse
Description

The objective of this study is to investigate the interaction between marijuana and quetiapine, with the goal of using this information to improve marijuana treatment outcome.

COMPLETED
Effects of Low-dose Naltrexone in Combination With a Range of Smoked Marijuana
Description

In heavy marijuana smokers, opioid receptor blockade increases the subjective and cardiovascular effects of marijuana. The current study was designed to clarify opioid-cannabinoid interactions by assessing how naltrexone shifts the dose-response function for marijuana-elicited effects in heavy marijuana smokers. For this within-subject, double-blind study, a marijuana smoking procedure was designed to characterize a dose-response relationship for marijuana's subjective and cardiovascular effects under blinded conditions.

COMPLETED
Medical Marijuana Use in HIV+ Patients Prospective Cohort Study
Description

The investigators are interested in understanding personal factors such as medical conditions and mental health, as well as social and economic factors, that influence marijuana (and other substance) use in HIV-positive patients. Several alternative hypotheses will be evaluated in the proposed project: 1. healthier patients may self-select marijuana use; 2. marijuana use may be associated with consequences that create barriers to seeking healthcare; 3. marijuana use may have medicinal value that reduces the need for such care.

COMPLETED
Brief Voluntary Alcohol and Drug Intervention for Middle School Youth
Description

We are currently working in 16 middle schools across Los Angeles, Santa Monica and Torrance to test out a voluntary after school program called Project CHOICE, which focuses on helping students decrease their alcohol and drug use. We are conducting surveys in all schools over three years and providing the intervention in 8 schools in the 2008-2009 school year and in the other 8 schools in the 2011-2012 school year. This is a program we have provided before in middle schools and we found that it was effective in curbing alcohol and drug use among students who voluntarily attended and among all students at the intervention school.

COMPLETED
An Effectiveness Trial of Project ALERT
Description

The purpose of this study is to replicate a longitudinal evaluation of Project ALERT, a substance abuse prevention program that targets middle school students.

UNKNOWN
Brief Counseling to Reduce Injuries Among Emergency Department Patients Who Report Alcohol and Substance Use
Description

The purpose of this study is to determine the effectiveness of two brief counseling sessions delivered to emergency department (ED) patients who report conjoint alcohol and marijuana use, in reducing injuries and other negative consequences, in comparison to an assessment only group.

COMPLETED
Motivation and Skills for Delta-9-tetrahydrocannabinol/Ethanol (THC/ETOH+) Teens in Jail
Description

This study will focus on treating substance abusing incarcerated teens using individually administered Motivational Interviewing (MI) followed by group Cognitive Behavior Therapy (CBT). The control group receives individualized Relaxation Training (RT) followed by group Treatment as Usual (TU). Currently, there is little research regarding effective group treatments for incarcerated teens and this study will address this gap in our knowledge base. We seek to reduce substance use and associated risky behaviors post-release (including driving under the influence, risky sexual behaviors, etc.)

COMPLETED
Adolescent Safer Sex Social Network Intervention
Description

Social networks are thought to hold the potential for shaping behavior on the grounds that social and situational factors more strongly influence behavior than do personality variables. This is a behavioral intervention study that will test a 6-session, small-group, peer-network intervention among adolescent males and females and their friends. The intervention primarily focuses on reducing risky sexual behavior and increasing condom use among adolescent males and females, aged 16-19. The concurrent use of alcohol and marijuana during sex is also a focus as these two substances are widely used among adolescents and fuel risky sexual behavior.

SUSPENDED
Transcranial Magnetic Brain Stimulation to Reduce Cannabis Use in Heavy Cannabis Users
Description

The growing legalization of cannabis across the U.S. is associated with increases in cannabis use, and accordingly, an increase in the number of individuals with cannabis use problems, including cannabis use disorder (CUD). While there are several medications being investigated as treatment options for CUD, none have been FDA-approved, and there is limited efficacy of traditional behavioral therapy approaches for this population. Consequently, there is a pressing need for the development of new treatments, including approaches that specifically target the brain areas associated with problematic cannabis use behaviors. Elevated attention to drug cues is one of the primary causes of relapse in heavy cannabis users. Preliminary data suggests that transcranial magnetic stimulation (TMS), a non-invasive form of brain stimulation, may be a novel brain-based tool to decrease heightened attention to drug cues in people with CUD. Building on prior data, the primary goal of this study is to evaluate the feasibility and effectiveness of TMS as a tool to decrease attention to drug cues and reduce cannabis use. This study will evaluate whether 2 weeks of rTMS can be used to decrease attentional bias to cannabis cues and reduce cannabis use in heavy cannabis users. We will recruit sixty (60) non-treatment seeking, near-daily cannabis users to receive 10 daily sessions of either real or sham (aka placebo) rTMS over a 2-week period. Participants will live on a residential research unit for 3 weeks. During the residential stay, data on cannabis use (measured using standard human laboratory measures of choice to smoke cannabis) and relevant brain activity (measured using drug cue exposure fMRI tasks) will be collected before and after the course of 10 daily rTMS sessions. We will aim to show whether real rTMS treatment reduces brain response and attentional bias to cannabis cues and reduces cannabis use levels.

Conditions
WITHDRAWN
Varenicline for the Treatment of Cannabis and Tobacco Use Disorders in Veterans
Description

After initial eligibility screening, Veterans who use both cannabis and tobacco will be randomly assigned to receive either varenicline (Chantix) or placebo for 12 weeks. Participants will attend weekly visits, in person or remotely, to provide breath and urine samples for testing, fill out questionnaires, and meet with study staff about medication compliance.

COMPLETED
Laboratory Study of Cannabidiol on the Effects of Smoked Marijuana
Description

The objective of this study is to assess the effects of oral cannabidiol (CBD; 0, 200, 400, 800 mg) on smoked marijuana's (0, 5.6% THC) subjective, reinforcing, cognitive, and cardiovascular effects. This experiment is expected to reveal CBD's intrinsic effects when combined with placebo marijuana, as well as its ability to modulate the behavioral effects of active marijuana.

COMPLETED
Laboratory Smoking of Marijuana "Blunts"
Description

This is a double-blind within-subjects clinical laboratory study comparing the product appeal and abuse liability-related subjective effects of different flavored cigar wrappers for marijuana blunts.

Conditions
NOT_YET_RECRUITING
Understanding the Clinical Pharmacology of Marijuana-Tobacco Co-administration
Description

This is a crossover, randomized, double-blinded clinical pharmacology study enrolling dual cannabis-tobacco smokers to better understand the combined effects of co-administering cannabis and tobacco. The project aims to describe the pharmacokinetics and pharmacodynamics of marijuana-tobacco co-administration by delivering THC and nicotine in various combinations. This foundational study will establish a research program focused on elucidating the public health consequences of marijuana-tobacco co-use.

COMPLETED
Project CheckUP: A Brief Behavioral Intervention for Quitline Callers Who Use Marijuana (MJ) and Tobacco
Description

Smoking cigarettes remains the number one preventable cause of death and disease in the US. Smokers who call tobacco quitlines and use marijuana struggle to quit tobacco due to the interactive effects of nicotine and marijuana. A recent study found that 25% of callers to state quitlines said they were using marijuana and 44% of those were interested in quitting or cutting back their marijuana use (in addition to wanting to quit smoking). The investigators propose to develop an integrated intervention for co-users of marijuana and tobacco to be delivered via state-funded quitlines. The investigators will incorporate key elements of an evidence-based brief behavioral intervention called 'The Marijuana Check-Up' into the tobacco quitline treatment. The investigators will evaluate the feasibility, acceptability and preliminary effects of the new intervention in a small randomized pilot study with 100 co-users recruited from four participating state quitlines. Outcomes measured at 3 months post randomization will include tobacco abstinence (biochemically verified) and days used marijuana. The investigators hypothesize that the intervention will: (1) be feasible to deliver (measured by coach treatment fidelity scores); (2) be acceptable to co-users (measured by enrollments into the study and call completion numbers); (3) increase tobacco cessation rates compared with standard quitline treatment; (4) increase co-users motivation to change MJ use; and (5) produce greater reduction in days using MJ compared with standard quitline treatment. The proposed brief behavioral intervention addressing co-use may increase quitline callers' chances of achieving and maintaining tobacco abstinence and increase participants' motivation to reduce marijuana use. As non-medicinal marijuana use becomes common and legal in more states, a low touch phone and web-based intervention for co-users of marijuana and tobacco could improve health outcomes for many. Findings will inform development of scalable public health intervention strategies for co-users easily implemented across quitlines.

COMPLETED
A Laboratory Model of Increasing Delta-9-tetrahydrocannabinol (THC) Potency on Cigarette Smoking
Description

The objective of the proposed research is to investigate how smoking increasing potency of THC (i.e., the psychoactive ingredient in marijuana) changes tobacco cigarette smoking behavior, urges, subjective effects, and abuse liability. This study will be a within-subjects, placebo-controlled study in our clinical laboratory of the effect of active vs. placebo marijuana on cigarette puff topography, exhaled carbon monoxide, urge, subjective effects, and abuse liability among 7 adults who smoke both marijuana and tobacco cigarettes.

Conditions
COMPLETED
Mobile Contingency Management for Marijuana and Tobacco Cessation
Description

The purpose of this pilot project is to pilot-test a combined cannabis and smoking cessation treatment. The intervention combines mobile technology with behavioral strategies, counseling, and medications.

COMPLETED
The Impact and Detection of Driving Impairments Associated With Acute Cannabis Smoking
Description

This study was authorized by the California Legislature (Assembly Bill 266, the Medical Marijuana Regulation and Safety Act to help with detection of driving under the influence of cannabis. One hundred and eighty healthy volunteers will inhale smoked cannabis with either 0% (placebo), 5.9%, or 13.4% Δ9-tetrahydrocannabinol (THC) at the beginning of the day, and then complete driving simulations, iPad-based performance assessments, and bodily fluid draws (e.g., blood, saliva, breath) before the cannabis smoking and a number of times over the subsequent 6 hours after cannabis smoking. The purpose is to determine (1) the relationship of the dose of Δ9-THC on driving performance and (2) the duration of driving impairment in terms of hours from initial use, (3) if saliva or expired air can serve as a useful substitute for blood sampling of Δ9-THC, and (4) if testing using an iPad can serve as a useful adjunct to the standardized field sobriety test in identifying acute impairment from cannabis.

COMPLETED
Effects of Marijuana Used on Lung Function in Persons With Chronic Obstructive Pulmonary Disease (COPD)
Description

The main hypothesis is that persons that smoke or smoked tobacco and marihuana have worsen lung function as compared with persons that only smoke or smoked tobacco.

RECRUITING
Effect of Cannabis on Cigarette Use Behavior
Description

The purpose of this study is to determine the impact of tetrahydrocannabinol (THC) administration on motivational, subjective, and physiological effects of cigarettes. The study's goals are to test demand for cigarettes, tobacco craving, affect, heart rate, blood pressure, expired breath carbon monoxide, and cognitive performance. Researchers will compare multiple doses of THC and a placebo in participants who smoke cigarettes and either smoke or vape THC in the laboratory.

COMPLETED
THC Crossover Study
Description

This is a randomized, crossover study enrolling experienced dual cannabis-tobacco smokers (N=18) to describe the differences in THC and toxicant exposure, examining pharmacokinetic, subjective, and cardiovascular effects from smoking and vaping dry herb cannabis. This study will also examine the differences in toxicant exposure and cardiovascular disease risk between smoking cannabis and smoking tobacco cigarettes.

COMPLETED
Families With Substance Use and Psychosis: A Pilot Study
Description

The purpose of this study is to develop and evaluate an intervention that adapts Community Reinforcement and Family Training (CRAFT) for families experiencing first episode psychosis and substance use delivered via telemedicine (video conferencing). The intervention aims to improve treatment engagement and reduce distress, and it will be delivered via telemedicine (CRAFT-FT). To assess feasibility of the intervention, family members will complete the sessions and provide feedback to refine the treatment manual. Data on client relatives with psychosis will be collected for preliminary assessment purposes. Client relatives will not complete the research study intervention.

COMPLETED
Choices4Health: Intervention to Prevent Substance-exposed Pregnancy
Description

This is a 4-year randomized, controlled study to test the efficacy of the CHOICES4Health-T (C4H-T) delivered by a computerized tablet, CHOICES4Health-C (C4H-C), delivered by a counselor, and brief advice (BA), on reducing preconception substance-exposed pregnancy risk (i.e. drinking below risk levels; tobacco and marijuana cessation; effective contraception use) among women (aged 18-44) presenting to the 13 primary care clinics that serve adults within the Harris Health System. Given the natural fit between contraceptive and HIV prevention counseling the CHOICES4Health interventions will also target HIV sexual risk behaviors.

COMPLETED
Screening Protocol for Research Participants
Description

The Screening Protocol is a system devised to evaluate potential research participants for National Institute on Drug Abuse/Maryland Psychiatric Research Center (NIDA/MPRC) studies.