definition of experimental drug use

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• Clinical Trials: What Patients Need to Know

Basics About Clinical Trials

What are clinical trials.

Clinical trials are research studies in which people volunteer to help find answers to specific health questions. When carefully conducted, they are the safest and fastest way to find new treatments and ways to improve health.

Clinical trials are conducted according to a plan, called a protocol, which describes:

• the types of patients who may enter the study
• the schedules of tests and procedures
• the drugs involved
• the dosages, or amount of the drug
• the length of the study
• what the researchers hope to learn from the study.

Volunteers who participate in the study must agree to the rules and terms outlined in the protocol. Similarly, researchers, doctors, and other health professionals who manage the clinical trials must follow strict rules set by the FDA. These rules make sure that those who agree to participate are treated as safely as possible.

Learn more about the basics of clinical trial participation, read first hand experiences from actual clinical trial volunteers, and see explanations from researchers at the NIH Clinical Research Trials and You Web site.

Why are clinical trials done?

Clinical trials are conducted for many reasons:

• to determine whether a new drug or device is safe and effective for people to use.
• to study different ways to use standard treatments or current, approved treatments so that they will be more effective, easier to use, or decrease certain side effects.
• to learn how to safely use a treatment in a population for which the treatment was not previously tested, such as children.

Who should consider clinical trials and why?

Some people participate in clinical trials because none of the standard (approved) treatment options have worked, or they are unable to tolerate certain side effects. Clinical trials provide another option when standard therapy has failed. Others participate in trials because they want to contribute to the advancement of medical knowledge.

Ensuring people from diverse backgrounds join clinical trials is key to advancing health equity. Participants in clinical trials should represent the patients that will use the medical products. This is often not the case—people from racial and ethnic minority and other diverse groups are underrepresented in clinical research. This is a concern because people of different ages, races, and ethnicities may react differently to certain medical products. Learn more about the clinical trial diversity initiative from the Office of Minority Health and Health Equity.

All clinical trials have guidelines, called eligibility criteria, about who can participate. The criteria are based on such factors as age, sex, type and stage of disease, previous treatment history, and other medical conditions. This helps to reduce the variation within the study and to ensure that the researchers will be able to answer the questions they plan to study. Therefore, not everyone who applies for a clinical trial will be accepted.

It is important to test drugs and medical products in the people they are meant to help. It is also important to conduct research in a variety of people, because different people may respond differently to treatments.  FDA seeks to ensure that people of different ages, races, ethnic groups, and genders are included in clinical trials. Learn more about FDA’s efforts to increase diversity in clinical trials .

Where are clinical trials conducted?

Clinical trials can be sponsored by organizations (such as a pharmaceutical company), Federal offices and agencies (such as the National Institutes of Health or the U.S. Department of Veterans Affairs), or individuals (such as doctors or health care providers). The sponsor determines the location(s) of the trials, which are usually conducted at universities, medical centers, clinics, hospitals, and other Federally or industry-funded research sites.

Are clinical trials safe?

FDA works to protect participants in clinical trials and to ensure that people have reliable information before deciding whether to join a clinical trial. The Federal government has regulations and guidelines for clinical research to protect participants from unreasonable risks. Although efforts are made to control the risks to participants, some may be unavoidable because we are still learning more about the medical treatments in the study.

The government requires researchers to give prospective participants complete and accurate information about what will happen during the trial. Before joining a particular study, you will be given an informed consent document that describes your rights as a participant, as well as details about the study, including potential risks. Signing it indicates that you understand that the trial is research and that you may leave at any time. The informed consent is part of the process that makes sure you understand the known risks associated with the study.

What should I think about before joining a clinical trial?

Before joining a clinical trial, it is important to learn as much as possible. Discuss your questions and concerns with members of the health care team conducting the trial. Also, discuss the trial with your health care provider to determine whether or not the trial is a good option based on your current treatment. Be sure you understand:

• what happens during the trial
• the type of health care you will receive
• any related costs once you are enrolled in the trial
• the benefits and risks associated with participating. 

What is FDA’s role in approving new drugs and medical treatments?

FDA makes sure medical treatments are safe and effective for people to use. We do not develop new therapies or conduct clinical trials. Rather, we oversee the people who do. FDA staff meet with researchers and perform inspections of clinical trial study sites to protect the rights of patients and to verify the quality and integrity of the data.

Learn more about the Drug Development Process .

Where can I find clinical trials?

One good way to find out if there are any clinical trials that might help you is to ask your doctor. Other sources of information include:

• FDA Clinical Trials Search. Search a database of Federally and privately supported studies available through clinicaltrials.gov. Learn about each trial’s purpose, who can participate, locations, and who to contact for more information.
• Clinicaltrials.gov. Conduct more advanced searches
• National Cancer Institute or call 1–800–4–CANCER (1–800–422–6237). Learn about clinical trials for people with cancer.
• AIDS Clinical Trials and Information Services (ACTIS) or call 1–800–TRIALS–A (1–800–874–2572). Locate clinical trials for people with HIV.
• AIDSinfo. Search a database of HIV/AIDS trials, sponsored by the National Institutes of Health’s National Library of Medicine.

What is a placebo and how is it related to clinical trials?

A placebo is a pill, liquid, or powder that has no treatment value. It is often called a sugar pill. In clinical trials, experimental drugs are often compared with placebos to evaluate the treatment’s effectiveness.

Is there a chance I might get a placebo?

In clinical trials that include placebos, quite often neither patients nor their doctors know who is receiving the placebo and how is being treated with the experimental drug. Many cancer clinical trials, as well as trials for other serious and life-threatening conditions, do not include placebo control groups. In these cases, all participants receive the experimental drug. Ask the trial coordinator whether there is a chance you may get a placebo rather than the experimental drug. Then, talk with your doctor about what is best for you.

How do I find out what Phase a drug is in as part of the clinical trial?

Talk to the clinical trial coordinator to find out which phase the clinical trial is in. Learn more about the different clinical trial phases and whether they are right for you.

What happens to drugs that don't make it out of clinical trials?

Most drugs that undergo preclinical (animal) research never even make it to human testing and review by the FDA. The drug developers go back to begin the development process using what they learned during with their preclinical research. Learn more about drug development .

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Patterns of use

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Drug use can be legal or illegal, high or low risk and beneficial or problematic depending on the circumstances.

Controlled use is considered sufficiently temperate to avoid harmful intoxication or dangerous use and the development of problematic dependence on a substance or substances.

Hazardous use refers drug use that puts ones safety and health in jeopardy.  This can include:

• Using at excessive level of a substance over a defined period
• Using a combination of substances which can interact dangerously
• Using substances in an unsafe manner such as sharing injecting equipment 

The UN (1997) also makes a distinction between first use and subsequent use.

First use is always experimental in the sense that a person is experiencing the effects of the drug for the first time.

Experimentation may involve only a single exposure to a drug’s effects. It may also involve several exposures, most often over the short term. Through experimentation a person might decide that the drug does not suit them and choose not to continue. Others who decide to continue using will adopt a pattern of use that works for them. People drug use patterns often change with time and circumstance and as tolerance to drug effects develop. Some people’s pattern of use develops beyond their control.

A range of substance use patterns, drawn from a number of sources (YSAS, 2001; Denning et al., 2004; Shafer, 1973), are represented in the following ‘continuum of usage patterns’. 

Continuum of Usage Patterns Non Use People choose not to use drugs for a number of reasons.  Some of these reasons relate to religion, culture or health.  In rare cases even non-use can be a very risky choice when drug use is required for “medical/therapeutic” purposes. First Use Experimental use: All people who use substances will go through a period of experimentation.  This process will determine how and if a person will use the drug subsequently (YSAS 2002). Subsequent Use Occasional use: This form of drug use is often circumstantial.  For example, a person may only drink alcohol at social functions or may only take paracetamol when they have a headache.  The more problematic form of occasional use would be binge style use, which can be quite intensive in short periods or bursts.  This too, is most often circumstantial (YSAS 2002). Regular social/recreational use: A person who uses drugs on a regular basis may or may not experience problems. Social/recreational use is likely to feature the least opportunity for harm. Regular, controlled users of drugs are not considered to be dependent on their drug of choice as they have the ability to moderate or change their use as circumstances dictate (YSAS 2002). Regular intensive use: There is no standardised method of categorising use as intensive or heavy. It depends on a range of factors including health and the norms of one’s group or culture.  People can consume large amounts of substances on a regular basis in a controlled way, without developing dependence. Alternatively this form of regular use can be hazardous and meet the criteria for ‘substance abuse’ (see DSM IV and ICD-10 classification) Dependent use: Some people come to depend or rely on one or more drugs in order to function and manage their circumstances.  People can be dependent on a drug and manage without problems occurring or engaging in high-risk behaviour.  If a person’s drug use does begin to impinge on other areas of their life such as family or work and the person is unable to change or moderate their use, they would be thought of as being dependent on that drug (see DSM IV and ICD-10 classification)

Figure 1 demonstrates how subsequent use will vary depending on the circumstances of each individual.  People may move from one type of use to another. 

Classifying substance dependence and abuse

The World Health Organisation International Classification of Diseases (ICD10) and the Diagnostic Statistical Manual (DSM) IV provide a complimentary set of criteria for defining substance dependence and abuse. 

ICD-10: F1x.2 Dependence syndrome A definite diagnosis of dependence should usually be made only if three or more of the following have been present together at some time during the previous year: (a) a strong desire or sense of compulsion to take the substance; (b) difficulties in controlling substance-taking behaviour in terms of its onset, termination, or levels of use;                     (c) a physiological withdrawal state (see F1x.3 and F1x.4) when substance use has ceased or been reduced, as evidenced by: the characteristic withdrawal syndrome for the substance; or use of the same (or a closely related) substance with the intention of relieving or avoiding withdrawal symptoms; (d) evidence of tolerance, such that increased doses of the psychoactive substances are required in order to achieve effects originally produced by lower doses (clear examples of this are found in alcohol- and opiate-dependent individuals who may take daily doses sufficient to incapacitate or kill nontolerant users); (e) progressive neglect of alternative pleasures or interests because of psychoactive substance use, increased amount of time necessary to obtain or take the substance or to recover from its effects; (f) persisting with substance use despite clear evidence of overtly harmful consequences, such as harm to the liver through excessive drinking, depressive mood states consequent to periods of heavy substance use, or drug-related impairment of cognitive functioning; efforts should be made to determine that the user was actually, or could be expected to be, aware of the nature and extent of the harm. Narrowing of the personal repertoire of patterns of psychoactive substance use has also been described as a characteristic feature (e.g. a tendency to drink alcoholic drinks in the same way on weekdays and weekends, regardless of social constraints that determine appropriate drinking behaviour). It is an essential characteristic of the dependence syndrome that either psychoactive substance taking or a desire to take a particular substance should be present; the subjective awareness of compulsion to use drugs is most commonly seen during attempts to stop or control substance use. This diagnostic requirement would exclude, for instance, surgical patients given opioid drugs for the relief of pain, who may show signs of an opioid withdrawal state when drugs are not given but who have no desire to continue taking drugs. http://www.who.int/substance_abuse/terminology/ICD10ClinicalDiagnosis.pdf

DSM‐IV‐TR Criteria for Substance Dependence A maladaptive pattern of substance use, leading to clinically significant impairment or distress, as manifested by three (or more) of the following, occurring at any time in the same 12‐month period (emphasis ours): 1. Tolerance, as defined by either of the following: A need for markedly increased amounts of the substance to achieve intoxication or desired effect or Markedly diminished effect with continued use of the same amount of the substance 2. Withdrawal, as manifested by either of the following: The characteristic withdrawal syndrome for the substance or The same (or a closely related) substance is taken to relieve or avoid withdrawal symptoms 3. The substance is often taken in larger amounts or over a longer period than was intended 4. There is a persistent desire or unsuccessful efforts to cut down or control substance use 5. A great deal of time is spent on activities necessary to obtain the substance (e.g., visiting multiple doctors or driving long distances), use the substance (e.g., chain‐smoking), or recover from its effects 6. Important social, occupational, or recreational activities are given up or reduced because of substance use 7. The substance use is continued despite knowledge of having a persistent physical or psychological problem that is likely to have been caused or exacerbated by the substance (e.g., current cocaine use despite recognition of cocaine‐induced depression, or continued drinking despite recognition that an ulcer was made worse by alcohol consumption) Criteria for Substance Abuse A maladaptive pattern of substance use leading to clinically significant impairment or distress, as manifested by one (or more) of the following, occurring within a 12‐month period: Recurrent substance use resulting in a failure to fulfil major role obligations at work, school, or home (e.g., repeated absences or poor work performance related to substance use; substance‐related absences, suspensions, or expulsions from school; neglect of children or household Recurrent substance use in situations in which it is physically hazardous (e.g., driving an automobile or operating a machine when impaired by substance use) Recurrent substance‐related legal problems (e.g., arrests for substance‐related disorderly conduct) Continued substance use despite having persistent or recurrent social or interpersonal problems caused or exacerbated by the effects of the substance (e.g., arguments with spouse about consequence of intoxication, physical fights) http://www.ncbi.nlm.nih.gov/books/NBK64247/

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Phases of Drug Use: From Experimentation to a Substance Use Disorder

In 2016, roughly 7.4 million  people over the age of 11 were affected by substance misuse or addiction. Everyone with a substance use disorder has a unique story about how they began to get involved with drugs. While many people with addiction can relate to each other, it’s important to remember that everyone’s experience is personal. Still, most people’s addiction spurred from several phases ranging from their first introduction to their spiral into dependency. Examining the different periods of drug use that eventually lead to addiction can help people understand where recreational drug use ends and where a dangerous substance use disorder begins.

• Introduction

A lot of people experiment with drugs or alcohol before reaching adulthood. The natural curiosity and rebellion of teenagers and young people usually cause the initiation into trying substances for the first time. With the help of some added peer pressure and desire to fit in, young people are most often at the most significant risk of exposure in early life. Because adolescents still don’t have fully developed prefrontal lobes in their brains, their judgment and impulse control is often shaky, making them vulnerable for potential misuse or addiction. A survey conducted by the Substance Abuse and Mental Health Services Administration (SAMHSA) showed that 2.8 million people above the age of 12 used an illicit drug for the first time in 2013. Every day, about 4,220 people under the age of 18 will use drugs and alcohol for the first time.

However, even people who abstained from an early introduction to substance use can still experience this stage later on in life. As adults, we deal with many stressful situations on the job, at home, and even personal struggles with mental health. This can prompt some people to self-medicate with drugs or alcohol, especially when they are emotionally compromised. Even those who are not dealing with personal issues may want to fit in with co-workers, friends, or even family members who may be misusing drugs recreationally. After this first introduction to a substance, people generally will decide to experiment further or decide against it.

• Experimentation

Upon the initial first try, drug use can quickly become experimental, occurring more frequently. Some people start this by only using drugs in a specific situation, like a party or during events like concerts. This exploratory phase is usually a more social matter that involves drugs as a way to relax or have some fun. At this point, people generally don’t seem to think about these substances too much other than right before the time they plan to use them. Cravings generally do not exist at this phase, but the anticipation of the social event of using the drug may become a factor. At this time people will decide to consciously consume drugs, understanding the potential consequences, or they will take the drugs impulsively, without much pre-planning. Still, their thoughts and concerns aren’t centered on their drug use, and will only take part when it is convenient.

• Recreational Use

Recreational drug use is more common than most people realize. Some use drugs to “party,” while others use them to unwind. When someone is regularly buying and ingesting drugs, it qualifies as recreational use that can be as frequent as every weekend or several times a week. At this stage, people are more aware of their intake and usually have a ritual surrounding their methods of obtaining and preparing the drugs. Sometimes they may miss work or school due to the after-effects of using the drugs. This drug use often goes hand-in-hand with people who are looking for drugs to escape their situations or cope with other issues. Others may use drugs regularly because they feel that it makes their social interactions much more exciting and enjoyable. At this point, they prefer to use drugs socially rather than stay sober.

When someone enters this phase, their drug use is considered to be risky and has become a problem. People that are misusing substances will sometimes have run-ins with dangerous situations like DWIs or other negative legal consequences. Their performance at work or school will be dwindling, and their relationships with loved ones are negatively impacted by their frequently unpredictable behavior. When someone is misusing drugs, they are beyond the point of regular recreational use and are walking the fine line between risky use and a substance use disorder. This is often the stage where people will first be approached by someone concerned about their frequent intoxication.

Drug dependency can be split into three parts: tolerance, physical dependence, and psychological dependence. When someone builds tolerance, they will require more and more of the drug they are misusing to achieve the desired effect. When a physical dependence occurs, it means that the person will go through withdrawal responses when they aren’t able to ingest their drug of choice. These withdrawals can range from light cravings to severe symptoms that can leave the user in significant pain. Psychological dependence happens when cravings are not only controlled by painful or bothersome withdrawals, but by the mental drive to use drugs. Some people who prefer to be ‘high’ constantly or under the influence are not able to face simple day-to-day tasks without their drug and require it to function. These three steps are cumulative and usually progress within several weeks or months of each other depending on the frequency of use.

• Substance Use Disorder (SUD)

When someone’s drug use has spiraled out of control, they will experience the following symptoms to fit the SUD criteria:

• They cannot control their use
• They continue to use despite drastically negative consequences
• They cannot function daily without their drug
• They have abandoned personal relationships and hobbies
• They have issues with the law
• Their health and life is in danger

Addiction is a disease that has developed from these long phases of drug use, carefully rewiring the brain’s reward pathway to constantly prioritize drug use over all else. Even when this person has attempted to cease their drug use, they have been unsuccessful and experienced dangerous relapses, returning to their previous behaviors. Usually, at this phase, people rarely can feel the high they once desired and continue to use the drug to keep withdrawal at bay.

The last stage of the substance use disorder progression is treatment , remembering however that treatment can begin at any phase of drug use. There are several treatment options for people who are faced with addiction that involve medication, behavioral therapy, and other counseling to help get them on the road to recovery.

Sources: https://www.stanfordchildrens.org/en/topic/default?id=stages-of-substance-abuse-1-3060

https://www.drugs.ie/drugs_info/about_drugs/the_nature_and_states_of_drug_use/

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• How Drug Addiction Affects Relationships
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