October 4, 2022

Drug Use & Regulation Describe the FDA approval process for assessing the safety and efficacy of a newly developed drug. What are advantages and disadvantages of this process? At Least

Discussion Topic- Drug Use & Regulation

Describe the FDA approval process for assessing the safety and efficacy of a newly developed drug. What are advantages and disadvantages of this process?

At Least 275 words.

**LO1, LO2, LO3**,

Course Materials:Required Text or E-Book: Drug Use and AbuseISBN-13:978-0-357-37595-2Authors : Stephen Maisto • Mark Galizio • Gerard Connors

Prescription CNS Depressants

https://www.drugabuse.gov/publications/drugfacts/prescription-cns-depressants

Chapter 5: Psychopharmacology and New Drug Development

Key Terms acute tolerance: A type of functional tolerance that occurs within a course of action of a single drug dose. attention deficit/hyperactivity disorder: A disorder with features such as a greater-than-normal amount of activity, restlessness, difficulty concentrating or sustaining attention, and impulsivity. behavioral pharmacology: The specialty area of psychopharmacology that concentrates on drug use as a learned behavior. behavioral tolerance: Adjustment of behavior through experience in using a drug to compensate for its intoxicating effects. brand name: The commercial name given to a drug by its manufacturer. causal relationship: A relationship between variables in which changes in a second variable are due directly to changes in a first variable. chemical name: The name given to a drug that represents its chemical structure. conflict paradigm: A research procedure that concerns the effects on a behavior of a drug that has a history of both reinforcement and punishment. control group: The reference or comparison group in an experiment. The control group does not receive the experimental manipulation or intervention whose effect is being tested. cross-tolerance: Tolerance to a drug or drugs never taken that results from protracted tolerance to another drug or drugs. dispositional tolerance: An increase in the rate of metabolizing a drug as a result of its regular use. drug discrimination study: A research procedure that primarily concerns the differentiation of drug effects. drug expectancy: A person’s anticipation of or belief about what they will experience upon taking a drug. functional tolerance: Decreased behavioral effects of a drug as a result of its regular use. generalizable: Applicability of a research finding from one setting or group of research participants to others. generic name: The general name given to a drug that is shorter (and easier for most people to say) than its chemical name. group design: A type of experimental design in which groups (as compared to individual cases) of subjects are compared to establish experimental findings. homeostasis: A state of equilibrium or balance. Systems at homeostasis are stable; when homeostasis is disrupted, the system operates to restore it. initial sensitivity: The effect of a drug on someone using it for the first time. paradoxical: Contrary to what is expected. A paradoxical drug effect is opposite in direction to what is expected based on the drug’s chemical structure. placebo control: A type of control originating in drug research. Placebo subjects have the same makeup and are treated exactly like a group of subjects who receive a drug, except that placebo subjects receive a chemically inactive substance. protracted tolerance: A type of functional tolerance that occurs over the course of two or more drug administrations. psychosis: A severe mental disorder whose symptoms include disorganized thinking and bizarre behavior.

Chapter 5: Psychopharmacology and New Drug Development

punisher: A consequence of a behavior that suppresses or decreases its future likelihood. reinforcer: A consequence of a behavior that increases its future likelihood.

reverse tolerance: Increased sensitivity to a drug with repeated use of it. self-administration study: A study that involves testing whether research participants will “give themselves” a drug.

True or False Questions Answer Key 1. Gender differences in the effects of drugs are due primarily to body weight differences. FALSE. Although men tend to be heavier than women, drugs tend to have a greater effect on women than on men because men tend to have less body fat. 2. Older individuals may have impaired metabolism of drugs, resulting in prolonged duration of drug action. TRUE. Enzymes involved in drug metabolism are often impaired with aging, resulting in drugs having a prolonged duration of action. 3. Expectancies about alcohol’s effects may be a more powerful determinant of its effects than the pharmacological action of alcohol. TRUE. Alcohol expectancies, especially at lower doses of alcohol, are powerful determinants of behaviors and emotions that normally are socially proscribed. 4. Theories about the effects of drugs on humans always have taken into account social and environmental factors. FALSE. The importance of social and environmental factors in understanding the effects of drugs on humans has been generally recognized only in the last 30 years. 5. Tolerance to a drug develops only because of biological changes that occur as a result of using the drug. FALSE. Important biological changes do seem to occur at the cellular level and they seem to explain tolerance in part. However, learning and environmental variables also seem related to demonstrations of tolerance. 6. Tolerance to a drug may be evident within the same occasion of using it. TRUE. For example, impairment in some behavior, like driving with a given concentration of alcohol in the blood, tends to be greater when the blood alcohol level is rising than it is at that same concentration when the level is falling. 7. People who have tolerance to alcohol will also demonstrate tolerance to barbiturates the first time they use them. TRUE. These people are demonstrating cross-tolerance to the two drugs, which have similar action in the body. 8. There is no relationship between the drugs that animals show preference for and the drugs that humans prefer. FALSE. Self-administration studies show that the drugs that animals “take” are similar to the ones subject to human use. Conversely, the drugs that animals tend not to self-administer are less prone to use by humans. 9. Pharmacological research conducted on animals can be generalized to humans. TRUE. Drug effects are similar in humans and nonhuman animals in many areas, including dosage, age, drug interactions, and environmental factors. Carefully conducted animal studies can further our understanding of human drug use. 10. In general, drug researchers are not concerned with placebo effects when studying the actions of a drug.

Chapter 5: Psychopharmacology and New Drug Development

FALSE. Expectancies and beliefs about a drug may influence what drug effects are experienced. Therefore, a “placebo control” group(s) is often included in drug experiments. 11. Because new medications are needed to treat diseases like AIDS, government regulation of the process of drug development and marketing has been greatly simplified. FALSE. Some of the regulations have been eased, resulting primarily in a potentially shorter time from drug discovery to distribution for public use. However, the process is still extensive and takes a considerable amount of time. 12. Folk uses of naturally occurring products are important sources for discovering new drugs. TRUE. Rediscovery of old folk medicines based on, for example, plants growing “wild” is an important source of creating new drugs.

Key Terms
True or False Questions Answer Key

Chapter 5

Psychopharmacology and New Drug Development

Icebreaker

• Who has ever used any kind of drug (including things like coffee , cigarettes, or over-the-counter products) and experienced any effects, good or bad, that you hadn’t expected? Raise your hand.

• When called on, briefly share with the class about your experience.

• In this chapter, we will learn more about psychopharmacology, including biological, psychological, social, and emotional factors that influence the effects you experience from drugs. [1520 minutes]

Chapter Objectives (1 of 2)

After studying this chapter, you will be able to…

5-1: Describe biological factors that may influence an individual’s drug experience 5-2: Describe psychological factors that may influence an individual’s drug experience 5-3: Discuss how social and environmental factors influence the drug effects people experience 5-4: Discuss contemporary theories to explain how tolerance to a drug develops 5-5: Apply principles of operant conditioning to explain drug use and drug dependence 5-6: Explain the behavioral pharmacology research methods of drug self- administration, drug discrimination, and conflict paradigm

Chapter Objectives (2 of 2)

After studying this chapter, you will be able to…(cont’d.)

5-7 Explain the behavioral pharmacology research methods of drug self- administration, drug discrimination, and conflict paradigm 5-8 Discuss the generalizability of research findings from studies based on animals to humans 5-9 Discuss the ethical concerns associated with conducting drug research on human participants 5-10 Explain the importance of placebo controls in experimental research 5-11 Describe the steps involved in testing and marketing of a new drug 5-12 Distinguish between Phase 1, Phase 2, and Phase 3 clinical trials

Factors Influencing Drug Effects

5.1

Factors Influencing Drug Effects: Biological and Psychological

• Biological factors: inherited differences in reactions to drugs—Initial sensitivity, gender, weight, age

• Psychological factors: personality (sensation seeking); “addictive personality”; drug expectancies and beliefs

Psychological Factors: Personality

People differ in how they react when they use drugs in a given setting as a result of differences in biological and psychological factors.

“I am an Addictive Personality, they say, a natural slave to passion— and many doctors have warned me against it. I am a High-risk Patient.”

Hunter S. Thompson

Drug Expectancies and Beliefs

“Over the course of socialization, people learn about drunkenness what their society ‘knows’ about drunkenness; and, accepting and acting upon the understandings thus imparted to them, they become the living confirmation of their society’s teachings.”

MacAndrew and Edgerton (1969, p. 88)

“You lose all your inhibitions when you’re drinking and you’ll be able to talk to people a lot easier. That’s what I say, you get more friendlier.”

Research participant (Bradizza et al., 2006)

Social and Environmental Factors

5.2

Social and Environmental Factors in Drug Effects

• Setting: Influences effects of alcohol, marijuana, hallucinogenic drugs; whether using alone or with others • Marijuana: Smokers viewed others as more intoxicated than they really were

(Carlin et al., 1972) • Setting found more influential with lower than higher doses of marijuana:

Experienced smokers “teach” new smokers what to expect, how to interpret effects, what effects to enjoy, what effects to ignore (Becker, 1963)

Tolerance

5.3

Tolerance: Types

Types of tolerance:

• Dispositional tolerance—Increase in the rate of metabolizing a drug with regular use

• Functional tolerance—Decreased behavioral effects of a drug with regular use

• Acute tolerance—A type of functional tolerance occurring within a single drug dose

• Protracted tolerance—A type of functional tolerance occurring over two or more drug doses

• Behavioral tolerance—Adjustment of behavior through experience in using a drug: Learned tolerance

• Cross-tolerance—Tolerance to a drug(s) never taken resulting from protracted tolerance to another drug(s)

Explanations of Tolerance

• Cell Adaptation Theory or homeostasis hypothesis • Plasticity of CNS

• Reduced synthesis of neurotransmitter • Reduced number of receptor sites: down regulation

• Drug Compensatory Reactions and Learning • Biological homeostatic counterreactions • Conditioned stimuli may elicit compensatory reactions

Knowledge Check 1: Tolerance

Type of ToleranceType of Tolerance

Match the type of tolerance on the left with its definition on the right.

1.Behavioral tolerance_______

2. Functional tolerance _______

3. Protracted tolerance _______

4. Dispositional tolerance ______

5. Acute tolerance _______

6. Cross-tolerance _______

DefinitionDefinition

a. Increase in the rate of metabolizing a drug with regular use

b. Tolerance to a drug never used resulting from tolerance to another drug

c. Occurs within taking a single drug dose

d. Decreased behavioral drug effects with regular use

e. Occurs over two or more drug doses

f. Adjustment through experience to compensate for drug effects

Knowledge Check 1: Answers

Type of ToleranceType of Tolerance

Match the type of tolerance on the left with its definition on the right.

1. Behavioral tolerance: f

2. Functional tolerance: d

3. Protracted tolerance: e

4. Dispositional tolerance: a

5. Acute tolerance: c

6. Cross-tolerance: b

DefinitionDefinition

a. Increase in the rate of metabolizing a drug with regular use

b. Tolerance to a drug never used resulting from tolerance to another drug

c. Occurs within taking a single drug dose

d. Decreased behavioral drug effects with regular use

e. Occurs over two or more drug doses

f. Adjustment through experience to compensate for drug effects

Behavioral Pharmacology

5.4

Behavioral Pharmacology: Terms and Topics

• Reinforcement and punishment

• Operant principles and drug dependence

• Drug discrimination study

• Conflict paradigm

Operant Principles and Drug Dependence: Hangovers

Knowledge Check 2: Behavioral Pharmacology

Term or TopicTerm or Topic

Match the term or topic on the left with its definition or characteristics on the right.

1. Reinforcer ________

2. Punisher ________

3. Conflict paradigm ________

4. Self-administration studies___

5. Drug administration studies___

6. Operant principles of drug dependence ________

Definition or CharacteristicsDefinition or Characteristics

a. Both reinforcement and punishment for the same behavior

b. Consequence increasing the likelihood of a behavior’s recurrence

c. Show that after receiving a drug, animals and people will take it again if they can

d. Show that continued drug use involves both positive and negative reinforcement

e. Consequence decreasing the likelihood of a behavior’s recurrence

f. Show that animals and people can differentiate among drugs and drug doses

Knowledge Check 2: Answers

Term or TopicTerm or Topic

Match the term or topic on the left with its definition or characteristics on the right.

1. Reinforcer b

2. Punisher e

3. Conflict paradigm a

4. Self-administration studies c

5. Drug discrimination studies f

6. Operant principles of drug dependence d

Definition or CharacteristicsDefinition or Characteristics

a. Both reinforcement and punishment for

the same behavior

b. Consequence increasing the likelihood of a behavior’s

recurrence

c. Show that after receiving a drug, animals

and people will take it again if they can

d. Show that continued drug use involves both positive and

negative reinforcement

e. Consequence decreasing the likelihood of a behavior’s

recurrence

f. Show that animals and people can

differentiate drugs and drug doses

Animal Models and Human Drug Use

5.5

Animal Models and Human Drug Use: Issues

• How generalizable to humans are findings from animal studies? • Remarkably good • Causal relationship established between drugs and functioning

• Ethical issues • Strict federal regulations guide treatment of animals • Three Rs in research planning:

1. Reduce the number of animals used to a minimum 2. Replace use of animals with alternatives if possible 3. Refine experimental methods to minimize potential pain or distress

Human Behavioral Pharmacology

5.6

Human Behavioral Pharmacology: Ethics

• Ethical Questions: Responsible, voluntary, informed consent of human participants

• Placebo Controls: Control group: enables placebo control (to rule out placebo effects) • Argument that it is unethical to give ill people placebos instead of a

somewhat effective alternative drug • However, only placebo control groups establish that the chemical action of

the drug being tested is responsible for the effects

New Drug Development

5.7

New Drug Development: Methods

Three ways new drugs are found:

• Rediscovery of traditional uses of naturally occurring products

• Accidental observation of an unexpected drug effect

• Synthesizing of known or novel compounds

Clinical Trials, FDA Approval: FDA guidelines must be met for a “new drug application” to be approved before marketing

• Three phases of clinical trials: • Phase 1: Healthy human volunteers, to determine safety • Phase 2: Humans diagnosed with target disease, to determine efficacy • Phase 3: Expands Phase 2 with more patients, less controlled trials

New Drug Development: Distribution and Marketing

Following clinical trials: Licensing and marketing approval; after-marketing evaluation of

clinical use, short-term and long-term effects

Commercial status: Drug is given a chemical name, brand name, generic name Generic drugs:

•Drug companies usually have sole rights to market a drug for 20 years after filing a

patent

•Generic drugs are equivalent in effect to brand names, but cost average 50% less

•Drug companies object to generics after all the time, money, and energy they spent on

getting approval, and losses incurred on drugs not approved

•Generic drugs lower the cost of health care, enabling better patient compliance

Discovery of New Drugs

Knowledge Check 3: New Drug Development

Question: Which of the following is true about generic drugs?

a. Drug companies can market a generic drug as soon as the brand-name drug has

been patented.

b. Generic drugs are not chemical copies of brand-name drugs and thus do not have

the same effects.

c. Patients are more likely to comply with prescriptions when generic versions are

more affordable.

Knowledge Check 3: Answer

Question: Which of the following is true about generic drugs?

a. Drug companies can market a generic drug as soon as the brand-name drug has been patented.

b. Generic drugs are not chemical copies of brand-name drugs and thus do not have the same

effects.

c. Patients are more likely to comply with prescriptions when generic versions are more affordable.

Answer: c. Patients are more likely to comply with prescriptions when generic versions are

more affordable. Drug companies cannot market generic drugs until the brand-name patent

expires, usually in 20 years. Generics are not chemical copies of brand-name drugs, but the

FDA says they do have the same effects.

Self-Assessment

• What parts of this chapter did you find most challenging, and thus need to review?

• Which things did you find most interesting in this chapter, and would like to study further? Why?

• What are some things you could best take away from this chapter and apply in real life, like at school, at work, or at home? How would you do this?

Summary

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Drug Use & Regulation Describe the FDA approval process for assessing the safety and efficacy of a newly developed drug. What are advantages and disadvantages of this process? At Least

Prescription CNS Depressants

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