BBH 451 Exam 2 Review Questions and
Complete Solutions
In Phase 1 of a clinical trial the drug is given to: ✅healthy humans
The Women's Health Initiative of hormone-replacement therapy, demonstrated that:
✅Random assignment of individuals is necessary to diminish the risk of false positive
findings
In clinical trials, the term blinding refers to: ✅The patient, or the physician, or both are
unaware of whether the patient is receiving the drug or placebo.
When an individual takes an inert substance and experiences effects that would be
experienced by someone taking the drug, the effects are known as: ✅placebo effects
Before the WHI was started there were arguments against doing a placebo-controlled
study of hormone replacement for menopause symptoms because: ✅Dozens of
studies have linked hormone replacement with lowered risk of cardiovascular problems
(previous studies were observational)
One of the conclusions about the original observational trials of hormone replacement
therapy was that there was a healthy user bias, which is: ✅People who reliably take
their medicine as prescribed are different from those who do not.
Phase 2 of a clinical trial of a drug is primarily concerned with ✅Efficacy in a
population with the disease or disorder
Behaviors that enable our survival and reproduction in the normal world are called
_______. ✅natural rewards
When observing the mesocorticolimbic system, we can see that the nucleus accumbens
releases _______ while the ventral tegmental area releases __________. ✅GABA;
dopamine
How are rewarding drug-taking stimuli and environment linked? ✅The rewarding
feeling of using a drug may cause it to be tied to the environment, causing cravings
when in the same environment.
Why are baseline levels of dopamine reduced after repeated drug use? ✅The brain
reduces dopamine production in response to artificial increases in dopamine from drugs
,The metabolism of fatty acids in the liver is disrupted by chronic abuse of what drug?
✅alcohol
Which types of receptors are affected by alcohol, and what effect does alcohol have on
those receptors? ✅Activation of GABAa receptors, inhibition of NMDA receptors
(GABA is a major inhibitory NT, you are inhibited when you drink)
If an individual had an increased level of alcohol dehydrogenase in their system but a
decreased level of acetaldehyde dehydrogenase, they would have _________ amounts
of acetaldehyde. This individual would have to drink ______ alcohol to feel the negative
effects. ✅Increased, less
A college friend can only have a single alcoholic drink before they get nauseous. What
is their most likely genetic combination for Alcohol and Acetaldehyde dehydrogenase?
✅Fast ADH2, Slow ALDH2
How would you expect Glutamate receptors to be affected in a chronic drinker? ✅more
receptors than normal
How many subunits and transmembrane domains do neuronal acetylcholine receptors
have? ✅5 subunits, 4 transmembrane domains
Curare and epibatidine both function at nicotinic acetylcholine receptors. How are their
effects related? ✅Curare is a nicotinic antagonist, while epibatidine is an agonist
What happens to the VTA when nicotine is introduced? ✅The VTA receives both
excitatory (glutamate from prefrontal cortex) and inhibitory signals from other brain
structures
What is the Nesbitt's Paradox? ✅Nicotine arouses the body, but smokers often feel
more relaxed after smoking
What is the major reason that nicotine patches are an imperfect treatment for smokers?
✅They increase nicotine gradually, while smoking provides nicotine right away
The goal of administering most drugs is to get the concentration to remain in a
therapeutic window (not too high not too low). If a nicotine patch can get the
concentration of nicotine into a therapeutic concentration and keep it there for long
period of time, why is it not a very effective tool to stop smoking? ✅The addictive
property of nicotine is, in part, the pulsatile changes in concentration, which is not
mimicked by the patch. In addition, the patch does not present the same queues that a
smoker is conditioned to associate with pleasure.
hypothesis ✅narrow idea
, theory ✅built on many studies (have good support)
T/F: p-values show proof ✅FALSE; probability
T/F: correlation implies causation ✅FALSE; correlation does not imply causation
reverse causation ✅B causes A
bidrectional causation ✅A causes B and B causes A
common causal variable ✅C causes A and B (usually a confounder)
indirect (mediator) variable ✅A causes C, which causes B
IND ✅Investigational New Drug. Pre-clinical testing on animals is done. Manufacturer
ready for human studies.
Phase 1 Clinical Trial ✅-safety, side-effects, toxicities; drug is tested on healthy
people, measures metabolism, excretion
-typical size= 20-80 people
Phase 2 Clinical Trial ✅-safety and efficacy (does an intervention to produce the
expected result under ideal circumstances)
-*test drug in diseases population*
-requires placebo control
-typical size= dozens-300 people
Phase 3 Clinical Trial ✅-safety and effectiveness (degree of beneficial effect under
"real world" clinical settings), test in different populations, doses, and with other drugs
-typical size= hundreds to thousands
-ethnicities can affect (genetic make-up)
Phase 4 Clinical Trial ✅-post market surveillance. side effects. v. large numbers
-optimal use and safety
average # of years clinical trials take to complete? ✅14 years; 6 pre-clinical, 8 clinical
efficacy ✅works in ideal environment/circumstances
effectiveness ✅works in "real-world" settings
Pre-clinical testing ✅-toxicity tested in rodens
-*most studies fail this stage*
Complete Solutions
In Phase 1 of a clinical trial the drug is given to: ✅healthy humans
The Women's Health Initiative of hormone-replacement therapy, demonstrated that:
✅Random assignment of individuals is necessary to diminish the risk of false positive
findings
In clinical trials, the term blinding refers to: ✅The patient, or the physician, or both are
unaware of whether the patient is receiving the drug or placebo.
When an individual takes an inert substance and experiences effects that would be
experienced by someone taking the drug, the effects are known as: ✅placebo effects
Before the WHI was started there were arguments against doing a placebo-controlled
study of hormone replacement for menopause symptoms because: ✅Dozens of
studies have linked hormone replacement with lowered risk of cardiovascular problems
(previous studies were observational)
One of the conclusions about the original observational trials of hormone replacement
therapy was that there was a healthy user bias, which is: ✅People who reliably take
their medicine as prescribed are different from those who do not.
Phase 2 of a clinical trial of a drug is primarily concerned with ✅Efficacy in a
population with the disease or disorder
Behaviors that enable our survival and reproduction in the normal world are called
_______. ✅natural rewards
When observing the mesocorticolimbic system, we can see that the nucleus accumbens
releases _______ while the ventral tegmental area releases __________. ✅GABA;
dopamine
How are rewarding drug-taking stimuli and environment linked? ✅The rewarding
feeling of using a drug may cause it to be tied to the environment, causing cravings
when in the same environment.
Why are baseline levels of dopamine reduced after repeated drug use? ✅The brain
reduces dopamine production in response to artificial increases in dopamine from drugs
,The metabolism of fatty acids in the liver is disrupted by chronic abuse of what drug?
✅alcohol
Which types of receptors are affected by alcohol, and what effect does alcohol have on
those receptors? ✅Activation of GABAa receptors, inhibition of NMDA receptors
(GABA is a major inhibitory NT, you are inhibited when you drink)
If an individual had an increased level of alcohol dehydrogenase in their system but a
decreased level of acetaldehyde dehydrogenase, they would have _________ amounts
of acetaldehyde. This individual would have to drink ______ alcohol to feel the negative
effects. ✅Increased, less
A college friend can only have a single alcoholic drink before they get nauseous. What
is their most likely genetic combination for Alcohol and Acetaldehyde dehydrogenase?
✅Fast ADH2, Slow ALDH2
How would you expect Glutamate receptors to be affected in a chronic drinker? ✅more
receptors than normal
How many subunits and transmembrane domains do neuronal acetylcholine receptors
have? ✅5 subunits, 4 transmembrane domains
Curare and epibatidine both function at nicotinic acetylcholine receptors. How are their
effects related? ✅Curare is a nicotinic antagonist, while epibatidine is an agonist
What happens to the VTA when nicotine is introduced? ✅The VTA receives both
excitatory (glutamate from prefrontal cortex) and inhibitory signals from other brain
structures
What is the Nesbitt's Paradox? ✅Nicotine arouses the body, but smokers often feel
more relaxed after smoking
What is the major reason that nicotine patches are an imperfect treatment for smokers?
✅They increase nicotine gradually, while smoking provides nicotine right away
The goal of administering most drugs is to get the concentration to remain in a
therapeutic window (not too high not too low). If a nicotine patch can get the
concentration of nicotine into a therapeutic concentration and keep it there for long
period of time, why is it not a very effective tool to stop smoking? ✅The addictive
property of nicotine is, in part, the pulsatile changes in concentration, which is not
mimicked by the patch. In addition, the patch does not present the same queues that a
smoker is conditioned to associate with pleasure.
hypothesis ✅narrow idea
, theory ✅built on many studies (have good support)
T/F: p-values show proof ✅FALSE; probability
T/F: correlation implies causation ✅FALSE; correlation does not imply causation
reverse causation ✅B causes A
bidrectional causation ✅A causes B and B causes A
common causal variable ✅C causes A and B (usually a confounder)
indirect (mediator) variable ✅A causes C, which causes B
IND ✅Investigational New Drug. Pre-clinical testing on animals is done. Manufacturer
ready for human studies.
Phase 1 Clinical Trial ✅-safety, side-effects, toxicities; drug is tested on healthy
people, measures metabolism, excretion
-typical size= 20-80 people
Phase 2 Clinical Trial ✅-safety and efficacy (does an intervention to produce the
expected result under ideal circumstances)
-*test drug in diseases population*
-requires placebo control
-typical size= dozens-300 people
Phase 3 Clinical Trial ✅-safety and effectiveness (degree of beneficial effect under
"real world" clinical settings), test in different populations, doses, and with other drugs
-typical size= hundreds to thousands
-ethnicities can affect (genetic make-up)
Phase 4 Clinical Trial ✅-post market surveillance. side effects. v. large numbers
-optimal use and safety
average # of years clinical trials take to complete? ✅14 years; 6 pre-clinical, 8 clinical
efficacy ✅works in ideal environment/circumstances
effectiveness ✅works in "real-world" settings
Pre-clinical testing ✅-toxicity tested in rodens
-*most studies fail this stage*
