Drug Use Studies at NIDA

Outcome inference in the sensory preconditioning task in opioid-use disorder

Study ID: 019

Currently screening participants for enrollment.

People with addictions often find it hard to choose the long-term benefits of abstinence over the short-term effects of using drugs. Based on studies in lab animals and humans, we think this is partly due to parts of the brain involved in certain types of learning and decision-making. We can test these basic functions using a simple task with pictures and odors.

The purpose of this study is to see whether performance in a learning task differs between people who have opioid-use disorder and people who don’t.

You may be eligible for this study if you meet all these criteria:

1. age between 21 and 60 years;
2. willing to fast for at least 6 hours before the study session and smell food odors;
3. if you have an opioid-use disorder, you must either
1. be abstinent for at least 3 weeks or
2. be in methadone or buprenorphine treatment

Design:
This study takes place at the National Institute on Drug Abuse Intramural Research Program (NIDA IRP) in Baltimore. It requires 1 visit for a lab session. The visit will take up to 5 hours.

Lab session. Before you come for the lab session, we’ll ask you not to eat or drink anything except water for at least 6 hours. When you get here:

• We’ll check you for signs of intoxication. If you’re intoxicated, we’ll have to reschedule the session.
• We’ll take a urine and breath sample to test for drugs and recent drinking. When you give the urine sample, you may be watched by a staff member of the same sex as you. If you’re female, we’ll test your urine to see if you’re pregnant. If you’re pregnant, you can’t stay in the study.
• We’ll give you tests of learning and behavior. The tests involve looking at shapes on a computer screen; those shapes will be paired with different food odors. After you’ve seen enough pairings, we’ll show you the shapes and ask you which odor you expect.
• To expose you to the odors, we’ll place a sterile tube under your nose. We’ll also monitor your breathing pattern with a belt around your upper abdomen. None of this should interfere with your natural breathing.
• About 30 days and 60 days later, participants will be called and asked about their drug use over the past 30 days.

Developing field tools for real-time assessment of exposure to psychosocial stress and drug use in an outpatient treatment population

Study ID: 020

Currently screening participants for enrollment.

Research shows that the environment is important in shaping who we are. Not much is known about how to measure the effects of stress from the environment. In this study we are developing methods to study how the environment may influence stress and drug use. We will also study the effects of genes on stress and drug use.

The main purpose of this study is to develop ways to measure how drug use and stress are affected by people’s neighborhood surroundings. To help us do this, we also need to measure differences in how people respond to stress in a lab setting.

Who Can Be In This Study: People between 18 and 75 who use heroin or other opioids, live or spend most of their time in or around Baltimore, are seeking treatment for opioid dependence, and can come to the Archway clinic three days a week.

Design:
In total, the study will last 30 weeks (about 7 months). You’ll be maintained on buprenorphine/naloxone (referred to as “buprenorphine” in this consent form) at Archway Clinic. You will come to the Archway Clinic two or three days a week and take-home medications for the other days. You will have to bring in a lockbox to show us that you can safely store the take-homes.

Weeks 1, 2 and 3 of Baseline Phase.

• You'll come to Archway (NIDA’s outpatient clinic) three days a week to get buprenorphine, including your take-home doses.
• The following things will start on week 1:
• During weeks 1-22, you will give urine and breath samples at each visit while being watched. Your breath will be tested for alcohol; your urine will be tested for other drugs. We’ll also ask you about your recent drug use.
• During your first week you will have a meeting with the counselor. After that, once a week, you can opt to attend individual drug counseling. Each session will last about an hour. This visit does not have to be on the same day as your medication visits.
• End of Week 2: You’ll be issued a smartphone to use as an Electronic Diary.
• Weeks 3-18: You can earn money for responding to prompts and for correct reporting on the smartphone.
• Week 2 to Week 30:
• Every two weeks you’ll fill out a few questionnaires about your employment, housing, use of health care stress and mood. This should take about 25 minutes each time.
• Week 19: You will return your smartphone.
• Weeks 19-22: Maintenance phase
• During this phase, you might be able to participate in a secondary study if you want to. If you do that, you won’t return your smartphone at week 19. Instead, you’ll keep it for a few more weeks, and earnings for returning the phone will be delayed until you complete the secondary study.
• If you’re not in a secondary study, you’ll just keep coming to the clinic two days a week to get your buprenorphine and give urine.
• Weeks 23-30: Optional medication taper.
• As week 22 approaches, you’ll have the following choices: (a) to remain in the study for an 8-week medication taper, (b) to try to transfer to another program, or (c) to request a 21-day taper.
• During these 8 weeks, your buprenorphine dose will be slowly reduced to zero. But if you prefer, we’ll try to help you transfer to another methadone or buprenorphine program instead.